NCT03768609

A Study to Evaluate the Effect of Cyclosporine, a P-Glycoprotein, Breast Cancer Resistance Protein, and Organic-Anion-Transporting Polypeptide Inhibitor, on Pimodivir in Healthy Adults

A Randomized, Open-label, Single-dose, 2-period, 2-sequence, Crossover, Phase 1 Study to Evaluate the Effect of Cyclosporine, a P-glycoprotein, Breast Cancer Resistance Protein, and Organic-anion-transporting Polypeptide Inhibitor, on the Pharmacokinetics of Pimodivir in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of a single oral dose of cyclosporine on the pharmacokinetics of a single oral dose of pimodivir when coadministered to healthy adult participants under fasted conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pimodivir	Participants will be administered pimodivir 600 mg orally as two tablets of 300 mg each.
DRUG	Cyclosporine	Participants will be administered cyclosporine 400 mg orally as 4 capsules of 100 mg each.

Timeline

• Start date: 2018-12-06
• Primary completion: 2019-03-06
• Completion: 2019-03-12
• First posted: 2018-12-07
• Last updated: 2019-04-29

Locations

1 site across 1 country: Belgium