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Healthy volunteers test new pill forms for rare blood disease
NCT ID NCT06291285
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different versions (a tablet and a capsule) of an experimental medicine called NDec, which is being developed for sickle cell disease. 44 healthy adults each took a single dose of both forms to see how the body absorbs them. The goal was to compare the two formulations, not to treat any disease.
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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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44 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Jun 2024
- 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 64 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 obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female. * Age 18 64 years (both inclusive) at the time of signing the informed consent. * Body weight between 60.0 and 100.0 kilogram (kg) (both inclusive) at screening. * Body mass index between 18.5-29.9 kilograms per square meter (kg/m\^2) (both inclusive). * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Platelet count greater than (\>) 400\*10\^9/ Liter (L) at visit 1 * Absolute neutrophil count less than or equal to (≤) 1.5\*10\^9/L at visit 1 * Female who is: 1. pregnant, breast-feeding or intends to become pregnant during the trial or within 6 months after the last dose of trial product or 2. of childbearing potential and not using highly effective contraceptive method and whose male partner is not using effective contraception, from screening until 6 months after the last dose of trial product * Male of reproductive age with female partner of childbearing potential who does not agree to use condoms and whose female partner of childbearing potential is not using a highly effective contraceptive measure (or adequate contraceptive measure as required by local regulation or practice) from signing the informed consent form (ICF) until 6 months after the last dose.
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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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ICON-Salt Lake City
Salt Lake City, Utah, 84124, United States
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Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
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