Safety and Pharmacokinetics of HU6

NCT05433506 | Completed Phase 1 FDA Drug

• 1 other identifier: RIV-HU6-103
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Twelve subjects will be randomized (1:1) to treatment sequence to determine the order in which they will receive the tablet or capsule formulation in Period 1 and Period 2. Part 2 is an open-label study of up to 4 single, ascending dose levels of HU6 administered as the tablet formulation. Eight subjects will be enrolled to participate in all of the ascending study periods.

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

• Assess the dose relationship of PK Parameter Cmax

  Following completion of each cohort, bioanalytical and the PK parameter Cmax will be analyzed.

  150 days

Study Arms (2)

Active Treatment: HU6 Tablet

EXPERIMENTAL

Drug: HU6 Tablet

Active Treatment: HU6 Capsule

EXPERIMENTAL

Drug: HU6 Capsule

Interventions

HU6 Tablet DRUG

Six subjects will receive a tablet formulation.

Active Treatment: HU6 Tablet

HU6 Capsule DRUG

Six subjects will receive the capsule formulation

Active Treatment: HU6 Capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Male or female between 18 and 55 years of age, inclusive, at time of informed consent.
• Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative urine serum pregnancy test at Screening and admission to CRU, and using, and agree to continue using, an effective method of contraception for at least 4 weeks or barrier method for 2 weeks prior to first study drug administration until 30 days after the last dose of study drug.
• Female subjects of non-childbearing potential must be surgically sterile (e.g., hysterectomy, bilateral tubal ligation, oophorectomy) or post-menopausal (no menses for \>1 year with follicle stimulating hormone (FSH) \>40 U/L at Screening).
• Female subjects of childbearing potential must not donate ova during the study and for at least 30 days after the last dose of study drug.
• Male subjects who have not had a vasectomy and/or subjects who have had a vasectomy but have not had 2 post surgery negative tests for sperm must agree to use an acceptable method of contraception from time of first dose of study drug until 30 days after the last dose of the study drug, and to not donate sperm during the study and for at least 30 days after the last dose of study drug.
• \. BMI between 28.0 and 45.0 kg/m2, inclusive. 3. Healthy per investigator judgment as documented by medical history, physical examination, vital sign assessments, 12-lead 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.
• \. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
• \. Willing and able to comply with the requirements of the study protocol.

You may not qualify if:

• Subjects presenting with any of the following will not qualify for entry into the study:
• 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 in consultation with the medical monitor, which may impact safety. History of cancer (except 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 in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of study treatment, such as, but not limited to, gastric bypass surgery or significant small bowel resections.
• Contraindication to study drug or its excipients and/or history of allergic or anaphylactic reactions or clinically significant allergic reaction.
• Resting heart rate \<45 or \>100 bpm, systolic blood pressure \<90 or \>160 mm Hg, or diastolic blood pressure \<50 or \>110 mmHg.
• On screening ECG and by history:
• A marked baseline prolongation of QT/QTcF interval (e.g., repeated demonstration of a QTcF interval \>450 msec for males and \>470 msec for females).
• A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) or a family history (immediate family member or grandparent \< 60 years of age) of sudden cardiac death of unknown origin.
• Use of any prescription medication or over-the counter medications (including multivitamins, herbal-containing preparations and products with cannabidiol \[CBD\]) within 14 days prior to admission to CRU.
• Exceptions:
• Hormonal contraceptives and hormone replacement therapies (oral, injectable, transdermal, or implanted) are permitted.
• Acetaminophen may be taken during screening and as needed to treat an AE during the study, but subjects should not receive acetaminophen within 24 hours of admission to the CRU.
• Ibuprofen (or other nonsterioidal anti-inflammatory drug \[NSAID\]) is prohibited within 7 days prior to admission to the CRU.
• Consumption of any food or drink/beverage containing grapefruit or grapefruit juice, apple or orange juice, pomelo juice, star fruit, Seville or Moro (blood) orange products within 7 days before admission to CRU. Vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts, mustard), food containing poppy seeds (e.g., muffins, bagels, and cakes) must not be consumed within 24 hours before admission to CRU.
• History of significant drug abuse (i.e, cocaine, phencyclidine, opioid derivatives including heroin, and amphetamine derivatives)within one year prior to Screening or frequent use of soft drugs (such as marijuana) within 1 month prior to the Screening visit, or hard drugs (such as cocaine, phencyclidine, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening. Marijuana use (and other tetrahydrocannabinol \[THC\] containing products) is prohibited within 7 days prior to Screening and throughout the study. .

Sponsors & Collaborators

• Rivus Pharmaceuticals, Inc.: lead

Study Sites (1)

Nucleus Network

Minneapolis, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Ferrer, MD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 is an open-label, randomized, Latin-square 2x2 crossover study. Part 2 is an open-label study of up to 4 single, ascending dose levels.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 27, 2022
• Study Start: September 15, 2022
• Primary Completion: January 30, 2023
• Study Completion: March 15, 2023
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

US (1)