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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Metformin

Criteria

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).