NCT03276858

Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers

A Double-Blind, Randomized, Placebo-Controlled, Single- And-Multiple-Dose Study to Evaluate the Safety, PK, and PD of CRN00808 in Healthy Volunteers and to Determine the Effect of CRN00808 on Midazolam PK

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase (one cohort of 8 subjects).

Detailed description

The single-dose phase initiates with ascending doses of an oral solution followed by a 3-way crossover food effect and bioavailability (capsule formulation) cohort. Serum IGF-1 levels and GHRH-analog stimulated GH levels will be assessed as pharmacodynamics measures. The first multiple-dose (7 days dosing) cohort will be initiated after the PK and safety data are available from the single-dose phase. Subsequent multiple-dose cohorts will have 10 days of dosing. Serum IGF-1 level and GH levels will be assessed as pharmacodynamics measures. The last cohort in the study is midazolam drug-drug interaction study. The dose will be selected based on review of all pharmacokinetic and safety data for the single-dose and multiple-dose cohorts completed. On Day 1, 8 subjects will receive a single oral 2 mg dose of midazolam. Starting on Day 3 through Day 8, subjects will receive daily doses of CRN00808. On Day 9, subjects will be administered CRN00808 and 2 mg midazolam together.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CRN00808	Investigational drug
DRUG	Placebo Oral Solution	Placebo
DRUG	Midazolam oral solution	Midazolam as part of the drug-drug interaction arm of the study
DRUG	Placebo oral capsule	Placebo

Timeline

• Start date: 2017-09-22
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2017-09-08
• Last updated: 2018-08-29

Locations

1 site across 1 country: Australia