A Phase 1, Dose-Escalation Study in Healthy Volunteers to Evaluate the Pharmacokinetics, Safety, and Tolerability of GS-1427 Following Single and Multiple Dosing

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000612819

Enrollment

Registered

2021-05-21

Start date

2021-06-15

Completion date

2022-03-03

Last updated

2023-02-06

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

Conditions

None listed

Brief summary

A Phase 1, randomized, placebo controlled, single and multiple ascending dose escalation study to evaluate the pharmacokinetics, safety and tolerability of GS-1427 in healthy subjects

Interventions

Two parts: - Part A: 5 cohorts Single Ascending Dose TBD during the study - Part B: 5 cohorts Multiple ascending dose based on Part A Mode of administration - oral capsule The adherence is completed by the site staff watching the participant take the drug and swallow it and then doing a visual check of their mouth to ensure it has been swallowed. Part A Cohort 1: GS-1427 single dose on Day 1 - 20mg Cohort 2: GS-1427 single dose on Day 1 - Upto 60mg Cohort 3: GS-1427 single dose on Day 1 - Upto 200mg Cohort 3: GS-1427 single dose on Day 8 - Upto 200mg Cohort 4: GS-1427 single dose on Day 1 - Upto 500mg Cohort 5: GS-1427 single dose on Day 1 - Upto 100mg Part B Cohort 6: GS-1427 twice daily for 14 days - Dose TBD Cohort 7: GS-1427 twice daily for 14 days - Dose TBD Cohort 8: GS-1427 twice daily for 14 days - Dose TBD Cohort 9: GS-1427 twice daily for 14 days - Dose TBD Cohort 10: GS-1427 once daily for 14 days - Dose TBD

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

- Be a non-smoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug - Have a calculated body mass index (BMI) of >19 and < 30 kg/m2 at screening - Must be willing and able to comply with all study requirements - Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs

Exclusion criteria

- Pregnant or Breastfeeding female - Have received any study drug within 30 days prior to study dosing - Subjects must not have donated blood within 56 days of study entry or plasma within 7 days of study entry. - Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment

Outcome results