A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Placebo Oral Capsule
- Conditions
- Healthy Volunteers
- Sponsor
- Crinetics Pharmaceuticals Inc.
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Number of participants with ECG abnormalities
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects 18 to 55 years of age, inclusive, at time of screening (Parts 1 and 2 only).
- •Males and females subjects 65 to 85 years of age at screening (Part 3 only).
- •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.
- •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.
- •Body mass index (BMI) of 18 to 32 kg/m2, inclusive at Screening.
- •Willing to provide signed informed consent.
Exclusion Criteria
- •Any uncontrolled or active major systemic disease which makes study participation unsafe or could interfere with evaluation of the endpoints of the study.
- •History or presence of malignancy within the past 5 years, not including treated basal cell carcinomas and in situ cervical neoplasia.
- •Use of any investigational drug within the past 60 days.
- •Have a medically significant abnormality observed during screening or admission.
- •Use of any prior medication without approval of the investigator within 14 days prior to admission.
- •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.
- •History of or current alcohol or substance abuse in the past 12 months
- •Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study.
Arms & Interventions
Elderly Cohort (Part 3)
Intervention: Placebo Oral Capsule
Single Ascending Dose (Part 1)
Intervention: CRN01941 Oral Solution
Single Ascending Dose (Part 1)
Intervention: CRN01941 Oral Capsule
Single Ascending Dose (Part 1)
Intervention: Placebo Oral Solution
Single Ascending Dose (Part 1)
Intervention: Placebo Oral Capsule
Multiple Ascending Dose (Part 2)
Intervention: CRN01941 Oral Solution
Multiple Ascending Dose (Part 2)
Intervention: CRN01941 Oral Capsule
Multiple Ascending Dose (Part 2)
Intervention: Placebo Oral Solution
Multiple Ascending Dose (Part 2)
Intervention: Placebo Oral Capsule
Elderly Cohort (Part 3)
Intervention: CRN01941 Oral Solution
Elderly Cohort (Part 3)
Intervention: CRN01941 Oral Capsule
Elderly Cohort (Part 3)
Intervention: Placebo Oral Solution
Outcomes
Primary Outcomes
Number of participants with ECG abnormalities
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with treatment emergent adverse events by severity
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with serious adverse events (SAEs)
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinical laboratory abnormalities
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Number of participants with clinically significant changes in vital signs
Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Secondary Outcomes
- Pharmacokinetics (AUC)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)
- Pharmacokinetics (Cmax)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)
- Pharmacokinetics (Tmax)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)
- Pharmacokinetics (T1/2)(Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8)