Heart check for sickle cell drug: early safety trial begins
NCT ID NCT07023029
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed phase 1 trial studied how etavopivat, a potential new medicine for sickle cell disease and thalassemia, affects the heart's electrical activity. Thirty-three healthy adults received single doses of etavopivat, a placebo, or an approved heart medication (moxifloxacin) to compare effects. The goal was to check for any heart rhythm changes before testing the drug in patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Etavopivat
- What this could lead to
- If successful, this study will confirm that etavopivat is safe for the heart, supporting its further development as a treatment for sickle cell disease and thalassemia.
- What could go wrong
- This is an early, small study in healthy volunteers, not patients. It only looks at heart effects, not whether the drug works for the disease. Unexpected heart risks could still emerge in larger trials.
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
-
33 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Sep 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 55 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: * Male or female. * Aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m\^2) (both inclusive) at screening. * Body weight above 40.0 kg at screening. * Considered to be generally healthy based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods, as defined in Appendix 4, Section 10.4. * Current participation (i.e., signed informed consent) in any other interventional clinical study. * Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (IMP) (if known), whichever is longer, before screening. * Any condition which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol. * Second or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms)., or of the corrected QT interval using the Fredericia formula (QTcF) over 450 ms for males and 470 ms for females, prominent U waves, or any other clinically significant abnormal ECG results or changes that make ECGs unsuitable for QT evaluations as judged by the investigator, at screening. * Use of tobacco and nicotine products, defined as any of the below: * Has used any product containing tobacco or nicotine within 90 days prior to screening. * Unable or unwilling to refrain from the use of any product containing tobacco or nicotine throughout the study. * Positive nicotine test at screening. * Participant is unable to refrain from or anticipates the use of antacids, iron, or any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphosphoglucuronosyltransferase (UGT) enzymes, cytochrome P450 (CYP) 3A4, CYP2C9 or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to dosing and throughout the study (Section 6.8). * Participant is unable to refrain from or anticipate the use of any medications or substances prohibited in the study (Sections 5.3, 5.5 and 6.8). A minimum of 20% African-American participants will be included in each part of this study. Efforts will be made to include at least 40 percentage (%) of each sex into each part of the study.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, 21225, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A phase 1, Open-Label, randomized, crossover study to evaluate the bioequivalence of soticlestat oral tablet formulations and the effect of food and tablet crushing on the pharmacokinetics of soticlestat in healthy adult participants
- A phase i, randomized, Double-Blind, Positive-Controlled, Parallel-Group pharmacokinetic clinical study of cetuximab injection versus erbitux in healthy male subjects
- A phase 1, Open-Label study to evaluate the effect of itraconazole and mefenamic acid on the Single-Dose pharmacokinetic profile of soticlestat in healthy participants
- A phase 1 Open-Label study to evaluate the Drug-Drug interaction of rifampin as a strong CYP3A inducer on soticlestat pharmacokinetics in healthy adult participants
- Comparative effects of three breathing techniques on heart rate variability, attention, reaction time, and anxiety in healthy adults: a randomized controlled trial
- An Open-Label phase 1 study to assess the safety, tolerability, and pharmacokinetics of a single dose of a new tablet formulation of TRTL-729 in healthy adults