An open-label, fixed sequence, crossover, 1-way drug-drug-interaction study between IMB-1018972 and each of repaglinide, midazolam, paroxetine, and fluvoxamine in healthy subjects
Completed
- Conditions
- Ischemic cardiovascular disease
- Registration Number
- NL-OMON48361
- Lead Sponsor
- Imbria Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
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
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- To assess the effects of multiple-dose IMB-1018972 on the single-dose<br /><br>pharmacokinetics (PK) of repaglinide and midazolam when coadministered in<br /><br>healthy subjects (Part 1)<br /><br>- To assess the effects of multiple-dose paroxetine on the single-dose PK of<br /><br>IMB1018972 when coadministered in healthy subjects (Part 2)<br /><br>- To assess the effects of multiple-dose fluvoxamine on the single-dose PK of<br /><br>IMB-1018972 when coadministered in healthy subjects (Part 3)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the safety and tolerability of IMB-1018972 when coadministered with<br /><br>repaglinide, midazolam, paroxetine, or fluvoxamine in healthy subjects (Parts<br /><br>1, 2, and 3)</p><br>