A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6

NCT06325930 | Completed Phase 1 FDA Drug

• 1 other identifier: RIV-HU6-105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, non-randomized, open-label Phase 1 study to characterize the absorption, metabolism, excretion, mass balance, pharmacokinetics (PK), safety and tolerability of HU6 following administration of a single dose of \[14C\]-HU6 in a fed state with a standard meal administered approximately 15 minutes prior to dosing.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• To assess the mass balance

  (i.e., the cumulative excretion of total 14C in urine and feces), of \[14C\]-HU6 following a single dose of \[14C\]-HU6, in healthy, adult male subjects

  Up to Day 29

Study Arms (1)

single dose of [14C]-HU6

EXPERIMENTAL

Drug: [14C]-HU6

Interventions

[14C]-HU6 DRUG

\[14C\]-HU6 following a single dose of HU6 in healthy, adult male subjects

single dose of [14C]-HU6

Eligibility Criteria

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

You may qualify if:

• Capable of understanding the written informed consent form (ICF), willingly provide valid, signed written informed consent and willing and able to comply with the schedule, requirements and restrictions of the study
• Healthy males between 18.0 and 55.0 years of age (inclusive) at the time of Screening.
• Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.5 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.
• Considered to be in good health by the Investigator, as determined by medical history, physical examination, vital signs (VS) measurements, 12-lead electrocardiogram (ECG), and clinical laboratory test results.
• Male subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:
• is documented to be surgically sterile (i.e., successfully vasectomized), or
• agrees to use 2 methods of highly effective contraception (e.g, condom plus spermicide) and female partner's use of a reliable form of contraception during intercourse for the duration of the study, and for at least 90 days after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 90 days post dose.

You may not qualify if:

• History or presence of any condition (e.g., chronic diarrhea), gastrointestinal bleeding, including related to hemorrhoids or prior surgery (e.g., gastric bypass) that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives.
• History of cancer that has not been in complete remission for \> 5 years (except basal cell skin cancer or squamous cell skin cancer with a history of curative treatment and no recurrence for \> 1 year prior to Screening), as judged by the Investigator.
• Acute illness within 14 days prior to study drug administration on Day 1, unless mild in severity and enrollment is approved by both the Investigator and Sponsor's medical representative.
• History of COVID symptoms or positive COVID test within 2 weeks prior to admission date.
• Any history of serious allergic drug reactions.

Sponsors & Collaborators

• Rivus Pharmaceuticals, Inc.: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center (CPC)

Baltimore, Maryland, 21201, United States

Location

Study Design

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

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 22, 2024
• Study Start: March 26, 2024
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 21, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)