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

NCT ID: NCT03936166

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-29

Study Completion Date

2019-12-16

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single and multiple-dose cohorts are placebo-controlled.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blind study

Study Groups

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Single Ascending Dose (Part 1)

Group Type EXPERIMENTAL

CRN01941 Oral Solution

Intervention Type DRUG

Investigational drug

CRN01941 Oral Capsule

Intervention Type DRUG

Investigational drug

Placebo Oral Solution

Intervention Type DRUG

Placebo

Placebo Oral Capsule

Intervention Type DRUG

Placebo

Multiple Ascending Dose (Part 2)

Group Type EXPERIMENTAL

CRN01941 Oral Solution

Intervention Type DRUG

Investigational drug

CRN01941 Oral Capsule

Intervention Type DRUG

Investigational drug

Placebo Oral Solution

Intervention Type DRUG

Placebo

Placebo Oral Capsule

Intervention Type DRUG

Placebo

Elderly Cohort (Part 3)

Group Type PLACEBO_COMPARATOR

CRN01941 Oral Solution

Intervention Type DRUG

Investigational drug

CRN01941 Oral Capsule

Intervention Type DRUG

Investigational drug

Placebo Oral Solution

Intervention Type DRUG

Placebo

Placebo Oral Capsule

Intervention Type DRUG

Placebo

Interventions

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CRN01941 Oral Solution

Investigational drug

Intervention Type DRUG

CRN01941 Oral Capsule

Investigational drug

Intervention Type DRUG

Placebo Oral Solution

Placebo

Intervention Type DRUG

Placebo Oral Capsule

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Crinetics Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Linear Clinical Research

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CRN01941-01

Identifier Type: -

Identifier Source: org_study_id