MedTrace Logo

Relative Bioavailability Study of HU6

NCT06486558 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-04-18

No results posted yet for this study

Summary

This is a 2-part study. Part 1 will assess the relative bioavailability of the new 450 mg tablet test formulation compared to the 150 mg capsule reference formulation (3 x 150 mg). Part 1 dosing will be conducted in the fasted state. Part 2 will assess the effect of food (and fat content) on the pharmacokinetics of the 450 mg tablet test formulation.

Conditions

  • Healthy

Interventions

DRUG

HU6 450 mg Tablet

new 450 mg tablet test formulation

DRUG

HU6 150 mg Capsules x 3 (Total dose = 450 mg)

150 mg capsule reference formulation (3 x 150 mg).

Sponsors & Collaborators

  • Rivus Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-24
Primary Completion
2024-11-15
Completion
2024-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486558 on ClinicalTrials.gov