Trial | NCT03276858  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    99
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.
Study Started
Sep 22
2017
Primary Completion
Apr 30
2018
Study Completion
Apr 30
2018
Last Update
Aug 29
2018

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

CRN00808 Oral Solution Experimental

CRN00808 oral solution, single-dose

CRN00808 Oral Capsule Experimental

CRN00808 oral capsule, single-dose and multiple-doses

Placebo Oral Solution Placebo Comparator

Placebo oral solution, single-dose

Placebo Oral Capsule Placebo Comparator

Placebo oral capsule, single-dose and multiple doses

Midazolam Oral Solution Other

Midazolam oral solution, two single-doses as part of the drug-drug interaction arm of the study

Criteria 

Inclusion Criteria:

BMI 18 to 30 kg/m2
Females postmenopausal or surgically sterile

Exclusion Criteria:

Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential
History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.
Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
Use of any prior medication without approval of the investigator within 14 days prior to admission
Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
History of alcohol or substance abuse in the past 6 months
Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study
No Results Posted