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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04814498




Registration number
NCT04814498
Ethics application status
Date submitted
22/03/2021
Date registered
24/03/2021

Titles & IDs
Public title
Drug-Drug Interaction (DDI) Study in Healthy Volunteers
Scientific title
A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers
Secondary ID [1] 0 0
B-0409-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug Drug Interaction 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Geneva Cocktail
Treatment: Drugs - BLD-0409

Experimental: Geneva cocktail (less fexofenadine) & BLD-0409 - Following an overnight fast of at least 10 hours, subjects will be administered IP in a fixed sequence.


Treatment: Drugs: Geneva Cocktail
Fixed sequence use of drug cocktail

Treatment: Drugs: BLD-0409
Fixed sequence use of active product
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the drug concentration-time curve from time zero to the last measurable concentration (AUC0-last)
Timepoint [1] 0 0
Up to 16 days
Primary outcome [2] 0 0
Maximum observed drug concentration (Cmax)
Timepoint [2] 0 0
Up to 16 days

Eligibility
Key inclusion criteria
1. Provide signed informed consent prior to study entry.
2. Males and females aged 18 to 55 years at the time of consent.
3. Body mass index (BMI) = 18 and = 32 kg/m2.
4. Agree to abstain from alcohol intake from 48 hours before first IP administration through to discharge from the CRU.
5. Agree to abstain from all caffeine- and xanthine-containing products (e.g., coffee, tea, cola drinks, chocolate) for 48 hours before first IP administration through to discharge from the CRU.
6. Have a negative urine drug screen/alcohol breath test at Day -1 (Admission). Repeat urine drug screens will be permitted for suspected false positive results.
7. Use of acceptable contraception.
8. Males must not donate sperm for at least 90 days after the last dose of study drug.
9. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test on Day -1. If a urine test is conducted and it is positive, a serum pregnancy test must also be performed for confirmation. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed by follicle-stimulating hormone (FSH) level > 40 mIU/mL at Screening.
10. In good general health, in the opinion of the Principal Investigator (PI), with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
11. Have clinical laboratory values within normal ranges.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Active smoker and/or user of nicotine-containing products (i.e., have not used nicotine-containing products within the previous 3 months).
2. Human immunodeficiency virus (HIV) antibody positive.
3. Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus (HCV) positive.
4. Presence of any underlying or clinically significant physical or psychological medical condition (e.g., hypertension, elevated cholesterol/triglycerides, asthma, or diabetes) that, in the opinion of the PI, would make it unlikely that the subject will complete the study per protocol.
5. History or presence of alcohol or drug abuse (including recreational marijuana use) within the 2 years prior to the first IP administration, and unwillingness to be totally abstinent during the period of confinement.
6. Blood donation or significant blood loss within 30 days prior to the first study drug administration.
7. Plasma donation within 7 days prior to the first study drug administration.
8. Administration of IP in another trial within 30 days prior to the first IP administration, or 5 half-lives, whichever is longer.
9. Females who are pregnant or breastfeeding.
10. Surgery within the past 3 months prior to the first IP administration determined by the PI to be clinically relevant.
11. Consumption of any nutrients known to modulate cytochrome P450 3A4 (CYP3A4) or any strong inhibitors or inducers of CYP3A4, starting from 14 days prior to the first dose of IP on Day 1 and until the EOS assessments.
12. Consumption of cruciferous vegetables or chargrilled meat more than 3 × per week in the previous 2 weeks.
13. Inability to refrain from consumption of grapefruit and Seville oranges or St. John's Wort within 14 days prior to the first dose of IP on Day 1 and until the EOS assessments.
14. Failure to satisfy the PI of fitness to participate for any other reason.
15. Active infection (diagnosed or suspected) or history of recurrent infections.
16. Active malignancy and/or history of malignancy in the past 5 years, except for completely excised non-melanoma skin carcinomas or low grade cervical intraepithelial neoplasia.
17. Serious local infection or systemic infection within 3 months requiring antibiotic treatment.
18. Any acute illness within 30 days prior to Day 1.
19. Use of any prescription or over-the-counter (OTC) medication (except for paracetamol and approved contraceptives) within 5 days or 5 half-lives (whichever is longer) prior to dosing and during course of study without prior approval of the Investigator and Medical Monitor. Simple analgesia (paracetamol) may be permitted at the discretion of the Investigator.
20. For all participants, the use of any estrogen-containing products (e.g., contraceptives, patch, cream, implants) within 14 days prior to the first study drug administration and until the EOS assessments.
21. Inability to refrain from vaccinations within 14 days of the first dose of IP and until the EOS assessments.
22. History of allergy or intolerance to any IP or IP constituents used on study or any clinically significant drug allergy as per the PIs judgment.
23. History of anaphylaxis or other severe allergic reaction to drug, food, toxin, or other exposure.
24. Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the IP.
25. Any evidence of cardiac disease or clinically significant abnormalities on ECG.
26. Systolic blood pressure (BP) > 150 mmHg or < 80 mmHg or diastolic BP > 90 mmHg or < 50 mmHg at Screening with one repeat allowed per the PIs discretion at Screening and Day -1.
27. Heart rate < 40 bpm or > 100 bpm at Screening with one repeat allowed per the PIs discretion at Screening and Day -1.
28. Diets that could alter metabolism (i.e., high protein, Slim Fast®, Nutrisystem®, etc.) within 7 days prior to dosing on Day 1.
29. Weight loss or gain of = 10% in the 30 days prior to dosing.
30. Strenuous exercise, including weightlifting, (> 5 × per week) within 2 weeks prior to first IP administration on Day 1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Other
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
3/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/01/2022
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Blade 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
Kristi McLendon, MD
Address 0 0
Nucleus Network
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/NCT04814498