Healthy Volunteers Clinical Trial
Official title:
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
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).
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.
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