Healthy volunteers test new heart Drug's body processing
NCT ID NCT07133191
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This completed Phase 1 trial studied how a single 16 mg dose of selatogrel is absorbed and processed in the body of 32 healthy volunteers (16 Japanese and 16 Caucasian). The study did not aim to treat any condition, but to gather safety and drug-level data. Participants stayed in the clinic for 3-4 days and had follow-up for about 70 days total.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Selatogrel (a reversible P2Y12 receptor antagonist given as a single injection)
This is an AI summary of the original study and may miss details. Read our disclaimer.
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
-
32 people
The number who actually took part.
- Started
-
Oct 2025
- Finished
-
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
-
20 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.
Main Inclusion Criteria: * Signed and dated informed consent form in a language understandable to the participants prior to any trial-mandated procedure. * Participant must be of either Caucasian (with European, North African, Middle Eastern origins) or Japanese ethnicity. * Body mass index (BMI) of 18.0 to 28.0 kg/m2 (inclusive) at Screening. * Systolic blood pressure 90-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the dominant arm, after 5 min in the supine position at Screening. * 12-lead electrocardiogram (ECG) without clinically relevant abnormalities, measured after 5 min in the supine position at Screening. * Clinical chemistry test results not deviating from the normal range to a clinically relevant extent at Screening. * Hematology and coagulation test results not deviating from the normal range to a clinically relevant extent at Screening and on admission. * Negative results from urine drug screen and alcohol breath test at Screening and on admission. * Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the requirements of the trial. * For participants of childbearing potential: Negative results from serum pregnancy test at Screening and urine pregnancy test on admission. They must consistently and correctly use (from Screening, during the entire trial, and for at least 30 days after trial intervention injection) an acceptable method of contraception, be sexually inactive, or have a vasectomized partner. If a hormonal contraceptive is used, it must be initiated at least 1 month before trial intervention administration. Main Exclusion Criteria: * Previous exposure to selatogrel. * Pregnant or lactating participant. * Known hypersensitivity to P2Y12 receptor antagonists or to excipients used in any of the formulations. * Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, transient ischemic attack, reasonable suspicion of vascular malformations, peptic ulcers. * Platelet count \< 120 × 109 L-1 at Screening or on admission. * Any known platelet disorder (e.g., Glanzmann thrombo-asthenia, von Willebrand disease, platelet release defect). * Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs, P2Y12 receptor antagonists, or any medication with blood-thinning activity (i.e., injectable or oral anticoagulants) within 3 weeks prior to trial intervention administration. * Treatment with another investigational small-molecule drug within 3 months or 5 × half-life (t1/2, whichever is longer) or with an investigational antibody treatment within 6 months prior to Screening, or participation in more than 4 investigational drug trials within 1 year prior to Screening. * Excessive caffeine consumption from trial drug administration to EOT, defined as ≥ 800 mg per day at Screening. * Nicotine use within 3 months prior Screening and inability to refrain from nicotine intake from Screening until EOT. * History or clinical evidence of alcoholism or drug abuse within 3 years prior to Screening. * Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) with the exception of contraceptives for participants of childbearing potential within 2 weeks or 5 × t1/2 (whichever is longer) prior to study drug administration. * History of major medical or surgical disorders, which in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed). * History of asthma. * Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. * Legal incapacity or limited legal capacity or vulnerability (e.g., kept in detention) at Screening. * Known hypersensitivity or allergy to natural rubber latex. * Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the trial. * Participant is the investigator or any delegate, research assistant, pharmacist, trial coordinator, other staff from trial site or the sponsor directly involved in the conduct of the trial or their relatives.
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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
-
CenExel ACT (Anaheim Clinical Trials)
Anaheim, California, 92801, United States
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