Status:
RECRUITING
Phase 1, Open-Label, Randomized, Study of the Safety and Pharmacokinetics of HU6
Lead Sponsor:
Rivus Pharmaceuticals, Inc.
Conditions:
Overweight
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for HU6 450 m...
Detailed Description
This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for 450 mg on...
Eligibility Criteria
Inclusion
- Male or female between 18 and 55 years of age at time of signing the informed consent.
- Body mass index (BMI) ≥ 25 kg/m2 at Screening.
- Medically stable in the opinion of the investigator based on medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this clinical protocol.
Exclusion
- Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease as determined by the investigator and if deemed necessary, in consultation with the medical monitor, which may impact safety.
- History of cancer (except for treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- Any surgical or medical condition or history that, in the opinion of the investigator, and if deemed necessary, in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of IMP, such as, but not limited to, gastric bypass surgery or gallbladder removal surgery or significant small bowel resections.
- Contraindication to IMP or its excipients and/or history of anaphylactic reactions or clinically significant allergic reaction.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT07170189
Start Date
September 1 2025
End Date
May 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Nucleus Network
Minneapolis, Minnesota, United States, 55114