Ischemic cardiovascular disease Ischemic cardiovascular disease
Conditions
Interventions
Part 1:
During the study the volunteer will receive multiple doses of IMB-1018972 and 2
single doses each of repaglinide and midazolam. IMB-1018972 will be given as an
oral capsule formulation. Repa
Sponsors
Imbria Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Gender : male or female. 2. Age : Part 1: 18 to 65 years, inclusive, at screening; Parts 2 and 3: 25 to 65 years, inclusive, at screening. 3. Body mass index : 18.0 to 32.0 kg/m2, inclusive, at screening. 4. Status : healthy subjects. 5. Race : Part 1: all races; Parts 2 and 3: Caucasian only
Exclusion criteria
Exclusion criteria: 1. Previous participation in the current study. 2. Employee of PRA or the Sponsor. 3. History of relevant drug and/or food allergies. 4. Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily; the use of tobacco products within 48 hours prior to admission to the clinical research center is not allowed. 5. History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To assess the effects of multiple-dose IMB-1018972 on the single-dose pharmacokinetics (PK) of repaglinide and midazolam when coadministered in healthy subjects (Part 1) - To assess the effects of multiple-dose paroxetine on the single-dose PK of IMB1018972 when coadministered in healthy subjects (Part 2) - To assess the effects of multiple-dose fluvoxamine on the single-dose PK of IMB-1018972 when coadministered in healthy subjects (Part 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the safety and tolerability of IMB-1018972 when coadministered with repaglinide, midazolam, paroxetine, or fluvoxamine in healthy subjects (Parts 1, 2, and 3) | — |
Countries
Netherlands
Outcome results
None listed