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Completed

NCT Number: NCT06048887

Single and Multiple-Ascending Dose Study of CRN04894 in Healthy Volunteers

A Phase 1, first-in-human, double-blind, randomized, placebo-controlled study to evaluate the safety of CRN04894 in healthy volunteers as well as the relationship between exposure and pharmacodynamic (PD) parameters.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS-Miami Research Associates

Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females must be either postmenopausal or surgically sterile; or using stable and permitted highly effective method of contraception - use of oral hormonal contraceptives are not allowed during the study
  • 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
  • ACTH-stimulated serum cortisol high-dose ACTH stimulation test conducted at Screening

Exclusion criteria

  • Use of topical, nasal, inhaled, or oral corticosteroids.
  • Use of any investigational drug within the past 60 days.
  • Have a medically significant illness within 30 days prior to screening.
  • Use of prohibited prescribed or nonprescribed medications and/or nonmedications/alternative medicinal products.
  • Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
  • Unstable psychological disorder ≤1 year prior to Screening.

Treatment and study plan

CRN04894 Oral Solution

Drug

CRN04894 is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

Placebo Oral Solution

Drug

Placebo

Primary outcomes

  1. Percentage of subjects with treatment-emergent adverse events

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

  2. Proportion of participants with a clinically significant safety laboratory observation

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

Secondary outcomes

  1. Pharmacokinetics (AUC)

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

    Assessment of the plasma area under the curve of CRN04894

  2. Pharmacokinetics (Cmax)

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

    Assessment of the maximum observed plasma concentration of CRN04894

  3. Pharmacokinetics (Tmax)

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

    Assessment of time to maximal CRN04894 concentration (Tmax)

  4. Pharmacokinetics (T1/2)

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

    Assessment of elimination half-life of CRN04894

Other outcomes

  1. Change in ACTH-stimulated serum cortisol

    Time frame: Part 1 - Day 1; Part 2 - Day 10

  2. Change in serum cortisol

    Time frame: Part 1 - up to Day 8; Part 2 - up to Day 20

Sponsors and collaborators

Lead sponsor

Crinetics Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CRN04894 in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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