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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05164614




Registration number
NCT05164614
Ethics application status
Date submitted
1/12/2021
Date registered
20/12/2021

Titles & IDs
Public title
Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule
Scientific title
A Phase I Study to Evaluate the Pharmacokinetics of Parathyroid Hormone (1-34) Administered Orally Via RaniPill™ Capsule
Secondary ID [1] 0 0
CP-0004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - RT-102 (80 µg)
Treatment: Drugs - Forteo
Other interventions - RT-102 (20 µg)

Experimental: RT-102 Group 1 - In 15 subjects, a RaniPill capsule containing 20 µg of PTH will be administered and serial blood samples will be collected for PK analysis.

Experimental: RT-102 Group 2 - In 15 subjects, a RaniPill capsule containing 80 µg of PTH will be administered and serial blood samples will be collected for PK analysis.

Active comparator: SC Group - In 10 subjects, 20 µg of Forteo will be administered subcutaneously and serial blood samples will be collected for PK analysis.

Experimental: Part 2; Group 1 - In up to 7 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy post-menopausal or surgically sterile with bilateral oophorectomy women.

Experimental: Part 2; Group 2 - In up to 12 subjects, once-a-day repeat dosing with RT-102 (20 mcg) for 7 days in healthy women.


Other interventions: RT-102 (80 µg)
RaniPill capsule containing PTH with doses of 20 and 80 µg

Treatment: Drugs: Forteo
A commercial formulation of PTH for SC control (20 µg)

Other interventions: RT-102 (20 µg)
RaniPill capsule containing PTH with dose of 20µg
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate Cmax of PTH administered via the RaniPill capsule
Timepoint [1] 0 0
Within 24 hours after ingestion of the device
Primary outcome [2] 0 0
Evaluate Tmax of PTH administered via the RaniPill capsule
Timepoint [2] 0 0
Within 24 hours after ingestion of the device
Primary outcome [3] 0 0
Evaluate AUC of PTH administered via the RaniPill capsule
Timepoint [3] 0 0
Within 24 hours after ingestion of the device
Secondary outcome [1] 0 0
Safety and tolerability of RT-102
Timepoint [1] 0 0
Within 24 hours after ingestion of the device

Eligibility
Key inclusion criteria
Part 1

1. Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
2. Willing to comply with all study procedures and available for the entire duration of the study
3. Participant is ambulatory female between 18 to 65 years of age.
4. BMI between 19 to 32 kg/m2.
5. In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
6. Non-menstruating, non-pregnant or non-lactating women during study participation NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening. Contraception (double barrier contraception and be protected by a daily combination birth control pill containing estrogen and progestin or any other form of hormonal contraceptive if cannot use the contraceptive pill) should be used between Screening visit and 30 days after dosing if actively engaged in penile-vaginal intercourse.

Part 2: Healthy Women

1. Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
2. Willing to comply with all study procedures and available for the entire duration of the study
3. Participant is ambulatory female between 18 to 65 years of age.
4. BMI between 19 to 32 kg/m2.
5. In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
6. Non-menstruating, non-pregnant or non-lactating women during study participation NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening. A double barrier approach using highly effective methods of contraception (e.g., oral contraceptives containing combined estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system [e.g., Mirena], progestogen-only hormonal contraception associated with inhibition of ovulation, nonhormonal intrauterine device, bilateral tubal occlusion) should be used between Screening visit and 30 days after dosing if actively engaged in penile-vaginal intercourse.

Part 2: Post-menopausal/surgically sterile

1. Participant understands and voluntarily signs the approved informed consent document prior to the performance of any study-specific procedures
2. Willing to comply with all study procedures and available for the entire duration of the study
3. Healthy ambulatory female post-menopausal for at least 1 year or surgically sterile with bilateral oophorectomy
4. BMI between 19 to 32 kg/m2.
5. In good health, determined by no clinically significant findings from medical history, physical examination, laboratory tests, and vital signs.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Part 1

1. Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
2. Participant has known history of intolerance of PTH (1-34)
3. Participant has known history of high levels of uric acid outside normal ranges
4. Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)
5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year
6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)
7. Participant has febrile illness within 30 days of the study procedures
8. Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
9. Participant currently treated with intravenous bisphosphonates for at least 1 month or oral bisphosphonates within the past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the treatment occurred 6 or more months prior to enrollment
10. Participants on a regimen of proton pump inhibitors (e.g. omeprazole) or histamine H2 receptor antagonists (e.g. ranitidine)
11. Participants with known bowel obstruction/stricture/fistula
12. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)
13. Participants who have undergone a recent (less than a month) barium X-ray procedure
14. Participants with known allergies or sensitivity to contrast media or barium sulfate
15. Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
16. Participants with congestive heart failure, renal failure
17. Presence of cardiac pacemaker or implanted electromedical device
18. Participant who is pregnant or lactating
19. Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer
20. Participant received COVID-19 vaccine within 7 days of dosing
21. Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
22. Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk

Part 2: Healthy Women

1. Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
2. Participant has known history of intolerance of PTH (1-34)
3. Participant has known history of high levels of uric acid outside normal ranges
4. Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)
5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year
6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)
7. Participant has febrile illness within 30 days of the study procedures
8. Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
9. Participant currently treated with intravenous bisphosphonates for at least 1 month or oral bisphosphonates within the past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the treatment occurred 6 or more months prior to enrollment
10. Participants on a higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 8.3.9 for details)
11. Participants on a H2 receptor antagonists (e.g. ranitidine)
12. Participants with known bowel obstruction/stricture/fistula
13. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)
14. Participants who have undergone a recent (less than a month) barium X-ray procedure
15. Participants with known allergies or sensitivity to contrast media or barium sulfate
16. Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
17. Participants with congestive heart failure, renal failure
18. Presence of cardiac pacemaker or implanted electromedical device
19. Participant who is pregnant or lactating
20. Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer
21. Participant received COVID-19 vaccine within 7 days of dosing
22. Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
23. Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk

Part 2: Post-menopausal/surgically sterile

1. Participants with known history of chronic constipation, gastroparesis / delayed gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis, esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative colitis
2. Participant has known history of intolerance of PTH (1-34)
3. Participant has known history of high levels of uric acid outside normal ranges
4. Participant has known history of osteoporosis or other bone disorders (such as Paget's disease)
5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or malabsorptive syndromes within the past year
6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment (including multi-vitamins containing calcium and/or vitamin D)
7. Participant has febrile illness within 30 days of the study procedures
8. Participant currently treated with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
9. Participant currently treated with intravenous bisphosphonates for at least 1 month or oral bisphosphonates within the past year (12 months). Subjects who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the treatment occurred 6 or more months prior to enrollment
10. Participants on a higher than the lowest approved therapeutic dose regimen of proton pump inhibitors (see Section 8.3.9 for details)
11. Participants on a H2 receptor antagonists (e.g. ranitidine)
12. Participants with known bowel obstruction/stricture/fistula
13. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II, Whipple, intestinal resection for any reason)
14. Participants who have undergone a recent (less than a month) barium X-ray procedure
15. Participants with known allergies or sensitivity to contrast media or barium sulfate
16. Participant with history of chronic disease that in the investigator's judgement may impact subject safety or study outcomes
17. Participants with congestive heart failure, renal failure
18. Presence of cardiac pacemaker or implanted electromedical device
19. Participant has received an investigational or marketed drug during a trial within the past 1 month or 5 half-lives of the investigational drug, whichever is longer
20. Participant received COVID-19 vaccine within 7 days of dosing
21. Participant is unlikely, in the investigator's judgment, to be able to complete participation in the study as required per study plan
22. Any other history which, in the investigator's judgment, makes the participant ineligible or places the participant at risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/10/2022
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RANI Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joshua Myers
Address 0 0
RANI Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05164614