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

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ClinicalTrials.gov Identifier: NCT03936166
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CRN01941 Oral Solution Drug: CRN01941 Oral Capsule Drug: Placebo Oral Solution Drug: Placebo Oral Capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single and multiple-dose cohorts are placebo-controlled.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind study
Primary Purpose: Treatment
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
Actual Study Start Date : April 29, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Arm Intervention/treatment
Experimental: Single Ascending Dose (Part 1) Drug: CRN01941 Oral Solution
Investigational drug

Drug: CRN01941 Oral Capsule
Investigational drug

Drug: Placebo Oral Solution
Placebo

Drug: Placebo Oral Capsule
Placebo

Experimental: Multiple Ascending Dose (Part 2) Drug: CRN01941 Oral Solution
Investigational drug

Drug: CRN01941 Oral Capsule
Investigational drug

Drug: Placebo Oral Solution
Placebo

Drug: Placebo Oral Capsule
Placebo

Placebo Comparator: Elderly Cohort (Part 3) Drug: CRN01941 Oral Solution
Investigational drug

Drug: CRN01941 Oral Capsule
Investigational drug

Drug: Placebo Oral Solution
Placebo

Drug: Placebo Oral Capsule
Placebo




Primary Outcome Measures :
  1. Number of participants with treatment emergent adverse events by severity [ Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 ]
  2. Number of participants with serious adverse events (SAEs) [ Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 ]
  3. Number of participants with clinically significant changes in vital signs [ Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 ]
  4. Number of participants with ECG abnormalities [ Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 ]
  5. Number of participants with clinical laboratory abnormalities [ Time Frame: Part 1 - up to Day 8; Part 2 - up to Day 20; Part 3 - up to Day 8 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (AUC) [ Time Frame: 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

  2. Pharmacokinetics (Cmax) [ Time Frame: 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

  3. Pharmacokinetics (Tmax) [ Time Frame: 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

  4. Pharmacokinetics (T1/2) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936166


Contacts
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Contact: Crinetics Clinical Trials 833-827-9741 clinicaltrials@crinetics.com

Locations
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Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Crinetics Pharmaceuticals Inc.

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Responsible Party: Crinetics Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03936166     History of Changes
Other Study ID Numbers: CRN01941-01
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pharmaceutical Solutions