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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CRN01941 Oral Solution; Drug: CRN01941 Oral Capsule; Drug: Placebo Oral Solution; Drug: Placebo Oral Capsule

• Registration Number: NCT03936166
• Lead Sponsor: Crinetics Pharmaceuticals Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study Start: 2019-04-29
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose (Part 1)	CRN01941 Oral Solution	-
Single Ascending Dose (Part 1)	CRN01941 Oral Capsule	-
Single Ascending Dose (Part 1)	Placebo Oral Solution	-
Single Ascending Dose (Part 1)	Placebo Oral Capsule	-
Multiple Ascending Dose (Part 2)	CRN01941 Oral Solution	-
Multiple Ascending Dose (Part 2)	Placebo Oral Capsule	-
Elderly Cohort (Part 3)	CRN01941 Oral Solution	-
Multiple Ascending Dose (Part 2)	CRN01941 Oral Capsule	-
Multiple Ascending Dose (Part 2)	Placebo Oral Solution	-
Elderly Cohort (Part 3)	CRN01941 Oral Capsule	-
Elderly Cohort (Part 3)	Placebo Oral Solution	-
Elderly Cohort (Part 3)	Placebo Oral Capsule	-

Primary Outcome Measures

Name	Time	Method
Number of participants with ECG abnormalities	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	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)	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	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	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (AUC)	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8	Assessment of the plasma area under the curve of CRN01941
Pharmacokinetics (Cmax)	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8	Assessment of the maximum observed plasma concentration of CRN01941
Pharmacokinetics (Tmax)	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8	Assessment of the time to reach Cmax for CRN01941
Pharmacokinetics (T1/2)	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8	Assessment of the elimination half-life of CRN01941

Trial Locations

Locations (1)

Linear Clinical Research; 🇦🇺 Perth, Western Australia, Australia