Trial | NCT02998450  Report issue

Title

A Study of IMR-687 in Healthy Adult Volunteers
A Phase 1a Study of IMR-687 in Healthy Adult Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Tovinontrine ...

  • Study Participants

    66
The purpose of this Phase 1a, first in human, randomized, double-blind, placebo-controlled study is to evaluate the safety, tolerability, PK and PD profile of the orally administered IMR-687 in healthy adult subjects.
Study Started
Oct 18
2016
Primary Completion
Jul 08
2017
Study Completion
Jul 08
2017
Last Update
Mar 08
2023

Drug IMR-687

1 of 6 possible single doses administered orally following overnight fast

Drug Placebo Oral Capsule

Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.

  • Other names: Microcrystalline cellulose

Cohort 1 Experimental

4 Subjects will receive a single low dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Cohort 2 Experimental

4 Subjects will receive a single low-mid dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Cohort 3 Experimental

4 Subjects will receive a single mid-low dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Cohort 4 Experimental

4 Subjects will receive a single mid dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Cohort 5 Experimental

4 Subjects will receive a single mid-high dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Cohort 6 Experimental

4 Subjects will receive a single high dose of IMR-687, administered orally following an overnight fast. 2 Subjects will receive a single dose of Placebo, administered orally following an overnight fast.

Criteria 

Inclusion Criteria:

Be healthy as judged by the Investigator on the basis of pre-study tests performed at Screening, with healthy body mass index (BMI), healthy body weight, and laboratory results within normal laboratory reference range or determined not to be clinically significant by the Investigator; and be free from drugs of abuse.

Exclusion Criteria:

Females who are pregnant, trying to become pregnant, or breastfeeding; and males with female partners who are trying to conceive.
Asthmatics or other individuals who use or may use albuterol rescue inhalers or nebulizers.
A significant history of cardiovascular disease.
On ECG, a QTcF >450 ms or the presence of clinically significant abnormalities as determined by the Investigator.
Elevated blood pressure.
Use within 30 days prior to Day 1 of any inhibitors or substrates of targets of IMR-687.
No Results Posted