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HU6 Bioavailability in Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Rivus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects of non-childbearing potential must be surgically sterile or post-menopausal
Female subjects of childbearing potential must be non-lactating, not pregnant, and using an effective method of contraception
Must not have
History of cancer or chemotherapy use within 5 years prior to Screening
Contraindication to study drug or history of allergic reactions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will be conducted in two parts. The first part will compare how the body absorbs a new 450 mg tablet compared to a 150 mg capsule. The second part will investigate how food,

Who is the study for?
This clinical trial is for healthy individuals. Specific details about who can join are not provided, but typically participants should have no significant health issues and be willing to follow the study procedures.
What is being tested?
The study is testing a new 450 mg tablet form of a drug called HU6 against its older version, which is taken as three 150 mg capsules. The first part checks how the body absorbs each form when fasting. The second part looks at how food affects absorption of the new tablet.
What are the potential side effects?
Since this trial involves healthy subjects and focuses on bioavailability (how well a drug is absorbed), side effects are not detailed here. However, common side effects in such studies might include digestive discomfort, headache, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who cannot have children because I am either surgically sterile or post-menopausal.
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I am not pregnant, breastfeeding, and I use birth control.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had cancer or chemotherapy within the last 5 years.
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I am not allergic to the study drug and have no contraindications.
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I have a long QT interval or risk factors for a specific heart rhythm problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Active Treatment HU6 450 mg tabletExperimental Treatment1 Intervention
Group II: Active Treatment HU6 450 mg Capsules (150 mg x 3)Experimental Treatment1 Intervention

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Rivus Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
554 Total Patients Enrolled
~0 spots leftby Oct 2024
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