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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03936166




Registration number
NCT03936166
Ethics application status
Date submitted
25/04/2019
Date registered
3/05/2019
Date last updated
4/11/2020

Titles & IDs
Public title
A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers
Scientific title
A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers
Secondary ID [1] 0 0
CRN01941-01
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 - CRN01941 Oral Solution
Treatment: Drugs - CRN01941 Oral Capsule
Treatment: Drugs - Placebo Oral Solution
Treatment: Drugs - Placebo Oral Capsule

Experimental: Single Ascending Dose (Part 1) -

Experimental: Multiple Ascending Dose (Part 2) -

Placebo Comparator: Elderly Cohort (Part 3) -


Treatment: Drugs: CRN01941 Oral Solution
Investigational drug

Treatment: Drugs: CRN01941 Oral Capsule
Investigational drug

Treatment: Drugs: Placebo Oral Solution
Placebo

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

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment emergent adverse events by severity
Timepoint [1] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Primary outcome [2] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Primary outcome [3] 0 0
Number of participants with clinically significant changes in vital signs
Timepoint [3] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Primary outcome [4] 0 0
Number of participants with ECG abnormalities
Timepoint [4] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Primary outcome [5] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [5] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary outcome [1] 0 0
Pharmacokinetics (AUC)
Timepoint [1] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary outcome [2] 0 0
Pharmacokinetics (Cmax)
Timepoint [2] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary outcome [3] 0 0
Pharmacokinetics (Tmax)
Timepoint [3] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary outcome [4] 0 0
Pharmacokinetics (T1/2)
Timepoint [4] 0 0
Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Eligibility
Key inclusion criteria
1. Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts
1 and 2 only).

2. Males and females subjects 65 to 85 years of age at screening (Part 3 only).

3. Females must be non-pregnant and non-lactating, postmenopausal by history and
confirmed by follicle stimulating hormone (FSH) >30 U/L at Screening, or surgically
sterile.

4. Male subjects must be surgically sterile or agree to use highly effective form of
contraception when sexually active with a female partner of child bearing potential.

5. Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.

6. Willing to provide signed informed consent.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any uncontrolled or active major systemic disease which makes study participation
unsafe or could interfere with evaluation of the endpoints of the study.

2. History or presence of malignancy within the past 5 years, not including treated basal
cell carcinomas and in situ cervical neoplasia.

3. Use of any investigational drug within the past 60 days.

4. Have a medically significant abnormality observed during screening or admission.

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

6. Subjects with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
infections. Subjects with previous hepatitis C infection that is now cured may be
eligible.

7. History of or current alcohol or substance abuse in the past 12 months

8. 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
29/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/12/2019
Sample size
Target
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, double-blind, randomized, placebo-controlled, single-dose and
multiple-dose study of CRN01941 in up to 119 healthy male and female subjects. This
single-center study will be conducted in 3 parts: a single-ascending dose phase (up to 8
cohorts, 8 subjects/cohort), a multiple-ascending dose phase (up to 5 cohorts, 9
subjects/cohort), and single dose phase in elderly subjects (1 cohort, 10 subjects).
Trial website
https://clinicaltrials.gov/ct2/show/NCT03936166
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03936166