Healthy volunteers test new drug capsule with and without food
NCT ID NCT07254286
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study looked at how taking a new drug called icovamenib with or without food changes the way the body absorbs it. Sixty healthy adults took the capsule in different conditions to measure drug levels in the blood. The goal was to gather information for future dosing, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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60 people
The number who actually took part.
- Started
-
Sep 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Informed Consent and Compliance 1. Must be able to understand a written informed consent, which must be obtained prior to initiation of study procedures. 2. Must be willing and able to comply with all study requirements. Baseline Characteristics 3. Healthy males or non-pregnant, non-lactating healthy females. 4. Body mass index (BMI) of 18.0 to 27.0 kg/m2 as measured at screening. 5. HbA1c ≤ 5.6%. 6. Fasting glucose ≤ 99 mg/dL. Exclusion Criteria: Medical/Surgical History and Mental Health 1. Mean QTcF interval greater than 440 msec on triplicate ECGs. Use of prescription or over-the-counter (OTC) medications known to significantly prolong the QT or QTcF interval. 2. History of hypertension or untreated hypertension (systolic blood pressure (BP) \>140 mmHg and/or diastolic BP \>90 mmHg). 3. Known self or family history (first-degree relative) of multiple endocrine neoplasia Type 1. 4. History of stomach or intestinal surgery or resection (except appendectomy, hernia and/or cholecystectomy). Diagnostic assessments. 5. Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator. 6. History or evidence of hepatitis C virus (HCV), or hepatitis B virus (HBV) infection or human immunodeficiency virus (HIV) at screening. 7. Estimated creatinine clearance (CLcr) of \<90 mL/min. 8. AST, ALT or bilirubin \> ULN at screening. 9. Prior Study Participation. 10. Subjects who have received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose. 11. Prior and Concomitant Medication. 12. Subjects who are taking, or have taken, any prescribed or OTC drug or herbal remedies (other than HRT/hormonal contraception and up to 4 g per day acetaminophen) in the 14 days before first study medication administration. 13. Currently dieting (formal weight loss program) and/or are currently using or have used within 2 months of screening any drugs for weight management. 14. Received prior menin inhibitor treatment.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Quotient Sciences - Miami, Inc.
Miami, Florida, 33126, United States
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