A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
Completed · Phase 1
Conditions studied: Healthy
In brief
Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib
Key facts
- Study ID
- NCT01551615
- Run by
- Sanofi
- People needed
- 14
- Starts
- 2012-03-01
- Expected to finish
- 2012-06-01
- Last updated by the study team
- 2016-08-29
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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).
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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