A Single and Multiple-Ascending Dose Study of CRN01941 in Healthy Adult Volunteers

Crinetics Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo Oral Solution; Drug: CRN01941 Oral Capsule; Drug: CRN01941 Oral Solution; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03936166

CRN01941-01

Details and patient eligibility

About

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).

Enrollment: 57 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 3 patient groups, including a placebo group

Single Ascending Dose (Part 1)

Experimental group

Treatment:

Drug: CRN01941 Oral Capsule

Drug: CRN01941 Oral Solution

Drug: Placebo Oral Capsule

Drug: Placebo Oral Solution

Multiple Ascending Dose (Part 2)

Experimental group

Treatment:

Drug: CRN01941 Oral Capsule

Drug: CRN01941 Oral Solution

Drug: Placebo Oral Capsule

Drug: Placebo Oral Solution

Elderly Cohort (Part 3)

Placebo Comparator group

Treatment:

Drug: CRN01941 Oral Capsule

Drug: CRN01941 Oral Solution

Drug: Placebo Oral Capsule

Drug: Placebo Oral Solution