CompletedPhase 1

Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart

United States27 participantsStarted 2023-05-12

Plain-language summary

To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to healthy volunteers.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Willing and able to give written informed consent and to comply with the requirements of the study for its duration.
✓. Healthy adult males or females aged 18 to 55 years, inclusive. As determined by the Investigator, healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results.
✓. A male subject is eligible to participate if he does not have a female partner who is pregnant or who intends to become pregnant during the study. Male subjects must agree to use contraception.
✓. Female subjects of childbearing potential must agree to use contraception.
✓. Body mass index (BMI) within 18.0 kg/m2 to 33.0 kg/m2, inclusively.

Exclusion criteria

✕. Female who is lactating.
✕. Positive pregnancy test at the Screening visit or check-in or planning to become pregnant within the next 6 months.
✕. Pulse rate less than 40 beats per minute (bpm) or more than 100 bpm at the Screening visit or check-in.
✕. A sustained supine systolic blood pressure \> 140 mm Hg or \< 90 mmHg or a supine diastolic blood pressure \> 90 mmHg or \< 50 mmHg at the Screening visit, check-in, or prior to dosing.
✕. History of significant hypersensitivity to rodatristat ethyl, moxifloxacin, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
✕. As determined by the Investigator, any known pre-existing medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to a history of clinically significant gastrointestinal (including cholecystectomy), hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, endocrine, immunologic, dermatologic or cardiovascular disease, including:
✕. History of Gilbert's Syndrome
✕. History of depression

What they're measuring

Evaluate the effect of rodatristat ethyl, rodatristat, and its major metabolites on the Fredericia-corrected QT interval in healthy volunteers using concentration-QT analyses following administration of multiple doses of rodatristat ethyl

Timeframe: 20 Days

Trial details

NCT IDNCT05933447

SponsorAltavant Sciences GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-28

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