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

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 - IMB1018972 SAD and MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48517

Enrollment

128

Registered

2019-01-28

Start date

2019-02-04

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure ischemic cardiovascular disease

Interventions

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 subjec

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)

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