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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03936166
• Other study ID #: CRN01941-01
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: November 2020
• Source: Crinetics Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CRN01941 Oral Solution
Investigational drug
• CRN01941 Oral Capsule
Investigational drug
• Placebo Oral Solution
Placebo
• Placebo Oral Capsule
Placebo

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of participants with ECG abnormalities		Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8
Primary	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	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
Secondary	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
Secondary	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
Secondary	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