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

A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN01941 in Healthy Volunteers

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo Oral Capsule; Drug: Placebo Oral Solution; Drug: CRN01941 Oral Solution; Drug: CRN01941 Oral Capsule

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Dose (Part 1)	Drug: Placebo Oral Capsule; Placebo; Drug: Placebo Oral Solution; Placebo; Drug: CRN01941 Oral Solution; Investigational drug; Drug: CRN01941 Oral Capsule; Investigational drug
Experimental: Multiple Ascending Dose (Part 2)	Drug: Placebo Oral Capsule; Placebo; Drug: Placebo Oral Solution; Placebo; Drug: CRN01941 Oral Solution; Investigational drug; Drug: CRN01941 Oral Capsule; Investigational drug
Placebo Comparator: Elderly Cohort (Part 3)	Drug: Placebo Oral Capsule; Placebo; Drug: Placebo Oral Solution; Placebo; Drug: CRN01941 Oral Solution; Investigational drug; Drug: CRN01941 Oral Capsule; Investigational drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 clinically significant changes in vital signs	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
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 clinical laboratory abnormalities	Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Crinetics Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): December 16, 2019
• Study Completion (Actual): December 16, 2019

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CRN01941-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No