Overweight
Conditions
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 mg once daily (QD) dose (as single or multiple tablets) or HU6 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD.
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 once daily (QD) dose (as single or multiple tablets) or 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD. Population pharmacokinetic (popPK) modeling indicated a potential difference in PK profile when multiple dose units are administered versus a single dose unit in tablet and capsule formulations.
Interventions
DRUGHU6
HU6 tablet or capsule
Sponsors
Rivus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax). | 28 days | To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on exposure parameters of maximum concentration (Cmax), after multiple dose administration of the tablet and capsule formulations of HU6 |
Countries
United States
Outcome results
None listed