Healthy volunteers help test if food changes drug absorption
NCT ID NCT07093398
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study looked at how taking a new drug called D3S-001 with or without food changes the way the body absorbs it. Twenty-six healthy adults took the drug once on an empty stomach and once after a meal. The goal was to see if food affects drug levels and to check for any side effects.
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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
-
26 people
The number who actually took part.
- Started
-
Jul 2025
- Finished
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Nov 2025
- Lead sponsor
-
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 65 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. * Males or females of any race, aged between 18 to 65 years, inclusive, with a body mass index between 18.0 and 32.0 kg/m2, inclusive. * In good health, determined by no clinically significant findings. Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder. * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. * History of stomach or intestinal surgery (including but not limited to cholecystectomy) or resection that would potentially alter absorption and/or excretion of orally administered drugs. * Unable or unwilling to consume the protocol-specified high-fat breakfast. Other protocol inclusion/exclusion criteria may apply.
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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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CMAX Clinical Research
Adelaide, South Australia, 5000, Australia
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