NCT03768388

Levoketoconazole Food Effect Study in Healthy Subjects

A Phase I Randomized, Open-Label, Two-Period, Two-Sequence Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Levoketoconazole in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Cortendo AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, randomized, open-label, single-dose, two-period, two-sequence crossover study in healthy male and female subjects to evaluate the effect of food on the PK of levoketoconazole.

Detailed description

In each period of the randomized, two period crossover study, levoketoconazole will be administered orally as a single dose of 600 mg levoketoconazole to subjects in the fasted state or fed (at 30 minutes after beginning consumption of a standardized high-fat meal). Subjects assigned to one treatment in Period 1 will be assigned to the opposite treatment in Period 2.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	levoketoconazole	food effect

Timeline

• Start date: 2018-11-30
• Primary completion: 2018-12-24
• Completion: 2018-12-24
• First posted: 2018-12-07
• Last updated: 2019-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study