A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib

Sanofi

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Vandetanib 800 mg

Drug: Metformin 1000 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01551615

D4200C00102

Details and patient eligibility

About

Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib

Full description

A Phase I, Open-label, Single-center Study to Assess the Pharmacokinetics of Metformin, an OCT2 Substrate, in Healthy Subjects When administered Alone and in Combination with a Single Oral Dose of Vandetanib (CAPRELSA) 800 mg

Enrollment

14 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males or females aged 18 to 50 years with a weight of at least 50 kg and a body mass index between 18 and 30 kg/m2 inclusive.
Females must have a negative pregnancy test at screening, must not be lactating and must be of non-childbearing potential.
Volunteers will be wild type for the OCT2 gene (as tested for within the last 6 months prior to Day 1 in Period 1)

Exclusion criteria

History or presence of gastrointestinal, hepatic, or renal disease or any medically significant disorder.
History of or ongoing severe allergy/hypersensitivity to drugs with a similar chemical structure or class to vandetanib or metformin.
Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center.
Known or suspected history of drug abuse.
Screening supine blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute.
Clinically significant current active skin disease (eg moderate to severe acne, psoriasis, eczema).
Any positive result on screening for serum hepatitis B, surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV).