New drug nacresertib gets first safety check in healthy volunteers
NCT ID NCT07600762
First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times
Summary
This early-stage study will test a single dose of the drug nacresertib in 12 healthy Japanese adults to see if it is safe and how the body processes it. The main goal is to check for side effects and measure drug levels in the blood. No treatment benefit is expected since participants are healthy volunteers.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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Apr 2026
- Finished
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Jun 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
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18 to 65 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: * Healthy Japanese male or female; 18 to 65 years of age at the time of screening. * Japanese participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. * BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. Exclusion Criteria: * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * History of any clinically significant sensitivity or allergy to any medication or food. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
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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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CenExel ACT- Anaheim Clinical Trials /ID# 282482
Anaheim, California, 92801, United States
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