A study comparing how fast the trial drug GS-6207 is processed and cleared from the body, in healthy adults and in adults with severely reduced kidney function.

A Phase 1 Open-Label, Parallel-Design, Single-Dose Study to Evaluate the Pharmacokinetics of GS-6207 in Participants with Normal Renal Function and Severe Renal Impairment

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000272998

Enrollment

Registered

2020-03-02

Start date

2020-06-15

Completion date

2020-11-05

Last updated

2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Medicines are cleared from the body in different ways. Some medicines are mainly cleared from the body by the kidneys. When the kidneys work less well, they are no longer able to clear those medicines as fast. This can lead to a build-up of medicine in the body, unless smaller or less frequent doses are used. Research suggests the kidneys are not very important in clearing GS-6207 from the body. The study team wants to confirm this by giving a single dose of GS-6207 to two groups of participants: adults with normal kidney function; and adults with severely reduced kidney function. The amount of GS-6207 in blood and urine after dosing will be measured, and the results of the two groups will then be compared. The study will also collect information about how safe and well-tolerated GS-6207 is in adults with normal and severely reduced kidney function.

Interventions

This study will test an experimental drug named GS-6207, which has been developed for the treatment of HIV infection. - the dose administered, 300 mg - the duration of administration, once - the mode of administration, oral tablet

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Healthy volunteers

Yes

Inclusion criteria

Be aged 18 through 79 years of age, inclusive, at screening Have a calculated BMI of (± 20%) 18 > BMI < 40 kg/m2 at screening Participants have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from study center admission, throughout the study period, and continuing for at least 60 days following the last dose of study drug

Exclusion criteria

Any prior exposure to GS-6207, unless allowed by the sponsor Have current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance or participant safety, or a positive drug or alcohol test at screening or baseline Have a positive test result for HIV-1/2 antibody, hepatitis B surface antigen, or hepatitis C virus antibody at screening

Outcome results