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

NCT03936166 | Completed Phase 1

• 1 other identifier: CRN01941-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (3)

Single Ascending Dose (Part 1)

EXPERIMENTAL

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

Multiple Ascending Dose (Part 2)

EXPERIMENTAL

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

Elderly Cohort (Part 3)

PLACEBO COMPARATOR

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

Interventions

CRN01941 Oral Solution DRUG

Investigational drug

Elderly Cohort (Part 3); Multiple Ascending Dose (Part 2); Single Ascending Dose (Part 1)

CRN01941 Oral Capsule DRUG

Investigational drug

Elderly Cohort (Part 3); Multiple Ascending Dose (Part 2); Single Ascending Dose (Part 1)

Placebo Oral Solution DRUG

Placebo

Elderly Cohort (Part 3); Multiple Ascending Dose (Part 2); Single Ascending Dose (Part 1)

Placebo Oral Capsule DRUG

Placebo

Elderly Cohort (Part 3); Multiple Ascending Dose (Part 2); Single Ascending Dose (Part 1)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (1)

Linear Clinical Research

Perth, Western Australia, 6009, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single and multiple-dose cohorts are placebo-controlled.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 3, 2019
• Study Start: April 29, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)