NCT05513625

Potential Influence of Esomeprazole on the Pharmacokinetics of Pritelivir

A Single-center, Open-label, 2-period Fixed-sequence Phase I Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Pritelivir

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: AiCuris Anti-infective Cures AG · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To investigate the effect of esomeprazole (ESO) on the pharmacokinetics of pritelivir (PTV), and to investigate the safety and tolerability of PTV.

Detailed description

This was a single-center, open-label, 2-period, fixed-sequence Phase 1 trial in 16 healthy adult male and female subjects (at least 7 subjects per sex). In the first period, subjects received treatment 1 (T1; single dose of 100 mg PTV on Day 1). In the second period, subjects received treatment 2 (T2: 40 mg qd ESO from Day -3 to Day 1 followed by a single dose of 100 mg PTV on Day 1). The wash-out period between PTV administrations in T1 and T2 was at least 4 weeks.

Conditions

• HSV Infection

Interventions

Type	Name	Description
DRUG	Pritelivir	oral administration
DRUG	ESO and pritelivir	oral administration

Timeline

• Start date: 2020-07-13
• Primary completion: 2020-10-13
• Completion: 2020-10-13
• First posted: 2022-08-24
• Last updated: 2024-02-22
• Results posted: 2023-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study