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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03276858




Registration number
NCT03276858
Ethics application status
Date submitted
5/09/2017
Date registered
8/09/2017
Date last updated
29/08/2018

Titles & IDs
Public title
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Dose Study to Evaluate the Safety, PK, and PD of CRN00808 in Healthy Volunteers and to Determine the Effect of CRN00808 on Midazolam PK
Secondary ID [1] 0 0
CRN00808-01
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
Treatment: Drugs - CRN00808
Treatment: Drugs - Placebo Oral Solution
Treatment: Drugs - Midazolam oral solution
Treatment: Drugs - Placebo oral capsule

Experimental: CRN00808 Oral Solution - CRN00808 oral solution, single-dose

Experimental: CRN00808 Oral Capsule - CRN00808 oral capsule, single-dose and multiple-doses

Placebo Comparator: Placebo Oral Solution - Placebo oral solution, single-dose

Placebo Comparator: Placebo Oral Capsule - Placebo oral capsule, single-dose and multiple doses

Other: Midazolam Oral Solution - Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study


Treatment: Drugs: CRN00808
Investigational drug

Treatment: Drugs: Placebo Oral Solution
Placebo

Treatment: Drugs: Midazolam oral solution
Midazolam as part of the drug-drug interaction arm of the study

Treatment: Drugs: Placebo oral capsule
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 single ascending doses using clinical assessments, telemetry, and Holter monitoring and subject self-reporting - ECG, clinical laboratory parameters, vital signs, physical examinations, telemetry, Holter monitoring
Timepoint [1] 0 0
Day 1 through Day 10
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of CRN00808 multiple ascending doses using clinical assessments and subject self-reporting - ECG, clinical laboratory parameters, vital signs, physical examinations
Timepoint [2] 0 0
Day 1 through Day 21
Secondary outcome [1] 0 0
AUC of CRN00808 single ascending doses - plasma AUC
Timepoint [1] 0 0
Day 1 through Day 7
Secondary outcome [2] 0 0
Cmax of CRN00808 single ascending doses - plasma Cmax
Timepoint [2] 0 0
Day 1 through Day 7
Secondary outcome [3] 0 0
t1/2 of CRN00808 single ascending doses - plasma t1/2
Timepoint [3] 0 0
Day 1 through Day 7
Secondary outcome [4] 0 0
Tmax of CRN00808 single ascending doses - plasma Tmax
Timepoint [4] 0 0
Day 1 through Day 7
Secondary outcome [5] 0 0
AUC of CRN00808 multiple ascending doses - plasma AUC
Timepoint [5] 0 0
Day 1 through Day 20
Secondary outcome [6] 0 0
Cmax of CRN00808 multiple ascending doses - plasma Cmax
Timepoint [6] 0 0
Day 1 through Day 20
Secondary outcome [7] 0 0
t1/2 of CRN00808 multiple ascending doses - plasma t1/2
Timepoint [7] 0 0
Day 1 through Day 20
Secondary outcome [8] 0 0
Tmax of CRN00808 multiple ascending doses - plasma Tmax
Timepoint [8] 0 0
Day 1 through Day 20
Secondary outcome [9] 0 0
Pharmacodynamics of CRN00808 in single ascending dose cohorts assessed by GHRH analog stimulated GH levels - Suppression of serum GH induced by a GH secretagogue
Timepoint [9] 0 0
Day -1 and Day 1
Secondary outcome [10] 0 0
Effect of CRN00808 on pharmacokinetics of midazolam - midazolam plasma AUC
Timepoint [10] 0 0
Day 1 through Day 10
Secondary outcome [11] 0 0
Effect of CRN00808 on Cmax of midazolam - midazolam plasma Cmax
Timepoint [11] 0 0
Day 1 through Day 10
Secondary outcome [12] 0 0
Effect of CRN00808 on t1/2 of midazolam - midazolam plasma t 1/2
Timepoint [12] 0 0
Day 1 through Day 10
Secondary outcome [13] 0 0
Effect of CRN00808 on Tmax of midazolam - midazolam plasma Tmax
Timepoint [13] 0 0
Day 1 through Day 10
Secondary outcome [14] 0 0
Relative bioavailability of capsule formulation - single-dose crossover arm only
Timepoint [14] 0 0
Day 1 to Day 7
Secondary outcome [15] 0 0
Effect of food on Cmax of CRN00808 - plasma Cmax compared with and without food in single dose arm
Timepoint [15] 0 0
Day 1 to Day 7
Secondary outcome [16] 0 0
Effect of food on AUC of CRN00808 - Plasma AUC compared with and without food in single dose arm
Timepoint [16] 0 0
Day 1 to Day 7
Secondary outcome [17] 0 0
Pharmacodynamics of CRN00808 in multiple ascending dose cohorts assessed by serum IGF-1 and GH - serum IGF-1 and GH
Timepoint [17] 0 0
Day -1 to Day 21

Eligibility
Key inclusion criteria
- BMI 18 to 30 kg/m2

- Females postmenopausal or surgically sterile
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any uncontrolled or active major systemic disease including, but not limited to:
acromegaly (with or without pituitary surgery or radiation therapy), cardiac,
pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological,
psychiatric, or neoplastic disorder with metastatic potential

- History or presence of malignancy within the past 5 years. Subjects who have been
successfully treated (for 3 months or longer) with no recurrence of basal or squamous
cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.

- Use of any investigational drug within the past 60 days or 5 half-lives, whichever is
longer

- Have a medically significant abnormality observed during screening or the admission
physical examination or in any other baseline measurements

- Use of any prior medication without approval of the investigator within 14 days prior
to admission

- Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis
C antibody (HCV-Ab) or has a history of a positive result

- History of alcohol or substance abuse in the past 6 months

- Any condition that in the opinion of the investigator would jeopardize the subject's
appropriate participation in this Phase 1 study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Crinetics Pharmaceuticals Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to
8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort),
and a midazolam drug-drug interaction phase (one cohort of 8 subjects).
Trial website
https://clinicaltrials.gov/show/NCT03276858
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MBBS PhD
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

Summary results
Other publications