A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Selgantolimod upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist

A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Selgantolimod upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist in healthy adults

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001019998

Enrollment

Registered

2020-10-07

Start date

2020-10-07

Completion date

2020-12-07

Last updated

2021-07-12

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 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9688 upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist in healthy adults

Interventions

Two Cohorts: - a Representative Proton Pump Inhibitor - H2-Receptor Antagonist Cohorts will be staggered with Cohort 1 enrolled, dosed and completed over a 10 day period prior to enrolling Cohort 2 and completion over a 23 day period. Meals will be provided to participants with the following make up: 1900 kcal/day (+- 5%), with breakfast consisting of 27% fat (162 kcal). Participants in Cohort 1 can not take part in Cohort 2. Participants in each cohort will receive all treatments. Cohort 1: Treatment A Single dose of Selgantolimod 1.5 mg administered orally (tablet) in the AM under fasted conditions (10 hours fasted except for water) on Day 1 Treatment B: Omeprazole 40 mg administered orally (capsule) once daily in the AM on an empty stomach (4 hours fasted except for water) on Days 4 – 8. Treatment C: Single dose of omeprazole 40 mg administered orally (capsule) in the AM 2 hours before a single dose of Selgantolimod 1.5 mg administered orally (tablet) under fasted conditions (10 hours fasted except for water) on Day 9. Cohort 2: Treatment D: Single dose of Selgantolimod 1.5 mg administered orally (tablet) in the AM under fasted conditions (10 hours fasted except for water) on Day 1 Treatment E: Single dose of Selgantolimod 1.5 mg co-administered orally (tablet) with famotidine 40 mg (tablet) in the AM under fasted conditions (10 hours fasted except for water) on Day 8 Treatment F: Single dose of famotidine 40 mg administered orally (tablet) in the PM (under fed conditions) of Day 14 approximately 12 hours before the AM dose of Selgantolimod 1.5 mg administered orally (tablet) under fasted conditions (10 hours fasted except for water) on Day 15. Treatment G: Single dose of famotidine 40 mg administered orally (tablet) in the AM 2 hours before a single dose of Selgantolimod 1.5 mg administered orally (tablet) under fasted conditions (10 hours fasted except for water) on Day 22.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

- Screening laboratory evaluations and 12-lead ECG evaluations must be without clinically significant abnormalities as assessed by the investigator - 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 - Have received any study drug within 30 days prior to study dosing - Have poor venous access that limits phlebotomy

Outcome results