The purpose of this study is to investigate how safe the new compound IMB-1018972 is and how well it is tolerated when it is administered to healthy volunteers. It will also be investigated how quickly and to what extent IMB1018972 is absorbed and…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the safety and tolerability of single and multiple ascending oral
doses of IMB1018972, single oral doses of trimetazidine, single oral doses of
MR formulations of IMB1018972, and multiple oral doses of the 200 mg 8-hour MR
formulation of IMB-1018972 in healthy subjects
Secondary outcome
To assess the pharmacokinetic (PK) profile of single and multiple ascending
oral doses of IMB1018972, single oral doses of trimetazidine, single oral
doses of MR formulations of IMB1018972, and multiple oral doses of the 200 mg
8-hour MR formulation of IMB-1018972 in healthy subjects
To assess the effect of food on the absorption and the PK profile of IMB
1018972 following a single oral dose of IMB1018972 in healthy subjects
To evaluate the effect of food on the safety and tolerability of IMB1018972
following a single oral dose of IMB1018972 in healthy subjects
To assess the absorption and PK profile of the 200 mg 8-hour MR formulation of
IMB-1018972 following multiple oral doses taken with food in healthy subjects
To evaluate the safety and tolerability of the 200 mg 8-hour MR formulation of
IMB-1018972 following multiple oral doses taken with food in healthy subjects
Background summary
IMB-1018972 is a new compound that may eventually be used for the treatment of
patients with angina.
Under normal conditions, the heart muscle uses fatty acids to generate energy
that is required to pump blood and this process requires oxygen. However, when
heart muscle doesn't get as much blood as it needs, glucose metabolism produces
more energy per oxygen molecule than fatty acid metabolism. IMB-1018972 shifts
the production of energy in the heart muscle from fatty acids towards glucose.
Study objective
The purpose of this study is to investigate how safe the new compound
IMB-1018972 is and how well it is tolerated when it is administered to healthy
volunteers. It will also be investigated how quickly and to what extent IMB
1018972 is absorbed and eliminated from the body (this is called
pharmacokinetics). In addition, the effect of food on the absorption of
IMB-1018972 in the body will be investigated (Groups 3 and 4 of Part 1 only).
In Group 5 of the study instead of IMB-1018972, trimetazidine will be
administered. Trimetazidine is a metabolite of IMB1018972, the compound which
has been administered to volunteers in the other groups of this study. Although
trimetazidine is an approved drug for angina and has been on the market in
Europe since 1987, not many details on pharmacokinetics are known of
trimetazidine. The Sponsor is interested in these details and therefore,
trimetazidine will be administered in Group 5 to investigate the
pharmacokinetics of trimetazidine.
In part 3 and 4 a modified-release tablet will be administered to the subjects.
Study design
The actual study will consist of 1 period (2 periods for Group 3) during which
the subject will stay in the research center for 4/17/8 days (3/16/7 nights).
The time between study compound administrations for Group 3 will be at least 1
week.
Day 1 is the first day of administration of the study compound. The subjects
will leave the research center on Day 3/17/7 of the study.
IMB-1018972 or placebo will be given as oral capsules or tablets with 240
milliliters (mL) of water.
Intervention
IMB-1018972 or placebo will be given as oral capsules or tablets with 240
milliliters (mL) of water.
For Group 3 only: During the first 4 hours after administration of the study
compound the subjects will not be allowed to lie down (except when indicated as
such by one of the investigators), as this may influence the uptake of the
study compound.
In Group 3, all volunteers will receive the study compound once without a
breakfast and once with breakfast. In the second period the subjects will
receive a high-fat breakfast with a standard composition, which must be started
exactly on time and must be finished within 20 minutes. The entire breakfast
must be consumed.
Study burden and risks
Drawing blood and/or insertion of the indwelling cannula may be painful or
cause some bruising.
In total, we will take a maximum of 200 milliliters of blood from the subjects.
This amount does not cause any problems in adults.
To make a heart tracing, electrodes (small, plastic patches) will be pasted at
specific locations on your arms, chest and legs. To monitor your heart rate,
electrodes (small, plastic patches) will be pasted at specific locations on the
chest and abdomen. Prolonged use of these electrodes can cause skin irritation
(rash and itching).
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Listed location countries
Age
Inclusion criteria
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.
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. 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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004576-35-NL |
| CCMO | NL68672.056.19 |