A FIRST-IN-HUMAN, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE ASCENDING DOSE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS (INCLUDING FOOD EFFECT) OF IMB1018972 IN HEALTHY SUBJECTS
- Conditions
- heart failureischemic cardiovascular disease10019280
- Registration Number
- NL-OMON48517
- Lead Sponsor
- Imbria Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 128
1. Gender: male or female.
2. Age:18 to 65 years, inclusive, at screening.
3. Body mass index : 18.0 to 32.0 kg/m2.
4. Status: healthy subjects.
5. At screening, females can be of childbearing potential (but not pregnant or
lactating), or of nonchildbearing potential (either surgically sterilized or
physiologically incapable of becoming pregnant, or at least 1 year
postmenopausal [amenorrhea duration of 12 consecutive months]); nonpregnancy
will be confirmed for all females by a serum pregnancy test conducted at
screening and each admission.
1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of relevant drug and/or food allergies.
4. Using tobacco products within 3 months prior to (the first) drug
administration.
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 safety and tolerability of single and multiple ascending oral<br /><br>doses of IMB1018972, single oral doses of trimetazidine, single oral doses of<br /><br>MR formulations of IMB1018972, and multiple oral doses of the 200 mg 8-hour MR<br /><br>formulation of IMB-1018972 in healthy subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the pharmacokinetic (PK) profile of single and multiple ascending<br /><br>oral doses of IMB1018972, single oral doses of trimetazidine, single oral<br /><br>doses of MR formulations of IMB1018972, and multiple oral doses of the 200 mg<br /><br>8-hour MR formulation of IMB-1018972 in healthy subjects<br /><br>To assess the effect of food on the absorption and the PK profile of IMB<br /><br>1018972 following a single oral dose of IMB1018972 in healthy subjects<br /><br>To evaluate the effect of food on the safety and tolerability of IMB1018972<br /><br>following a single oral dose of IMB1018972 in healthy subjects<br /><br>To assess the absorption and PK profile of the 200 mg 8-hour MR formulation of<br /><br>IMB-1018972 following multiple oral doses taken with food in healthy subjects<br /><br>To evaluate the safety and tolerability of the 200 mg 8-hour MR formulation of<br /><br>IMB-1018972 following multiple oral doses taken with food in healthy subjects</p><br>