NCT03880825

Drug Interaction Study of Levoketoconazole and Metformin

A Phase I Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Levoketoconazole on the Single-Dose Pharmacokinetics of Metformin in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Cortendo AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.

Detailed description

This study will enroll healthy male and female subjects to evaluate the effect of levoketoconazole on the PK of a single 500 mg dose of metformin. There will be 3 sequential treatment periods, and all subjects will receive metformin only in Period 1, escalating doses of levoketoconazole in Period 2, and concurrent administration of metformin and levoketoconazole in Period 3.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Metformin 500 mg Oral Tablet	single dose
DRUG	Levoketoconazole 150 - 600 mg (BID)	escalating dose from 150 mg to 600 mg (BID)

Timeline

• Start date: 2019-03-28
• Primary completion: 2019-05-03
• Completion: 2019-05-03
• First posted: 2019-03-19
• Last updated: 2019-08-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study