Clinical trial NCT03936166: A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single and multiple-dose cohorts are placebo-controlled.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of participants with treatment emergent adverse events by severity
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Number of participants with clinically significant changes in vital signs
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Number of participants with ECG abnormalities
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary outcomes:
measure: Pharmacokinetics (AUC)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Pharmacokinetics (Cmax)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Pharmacokinetics (Tmax)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
measure: Pharmacokinetics (T1/2)
timeFrame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
References: