NCT03826602

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin

A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effects of Tucatinib of the Pharmacokinetics of Metformin in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is being done to look at how tucatinib might affect the way another drug (metformin) works. It will look at healthy volunteers and how tucatinib affects how the body absorbs metformin. This will help us find out whether tucatinib is safe to give together with metformin. The study will also look at how tucatinib affects how the kidneys work.

Detailed description

This is a single center, fixed-sequence, drug-drug interaction study to assess the effects of multiple oral doses of tucatinib on the pharmacokinetics of a single oral dose of metformin in healthy subjects. The primary objective of the study is to assess the effects of tucatinib on the single-dose PK of metformin. Secondary objectives of the study are to (1) assess the safety and tolerability of metformin when coadministered with tucatinib and (2) assess the effects of tucatinib on renal function using iohexol as glomerular filtration rate (GFR) marker.

Conditions

• Drug-drug Interaction

Interventions

Type	Name	Description
DRUG	Tucatinib	150mg administered orally twice daily
DRUG	Metformin	850mg administered orally
DRUG	Iohexol	1500 mg administered intravenously (IV)

Timeline

• Start date: 2019-02-12
• Primary completion: 2019-03-08
• Completion: 2019-03-15
• First posted: 2019-02-01
• Last updated: 2019-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study