A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
- Registration Number
- NCT01551615
- Lead Sponsor
- Sanofi
- Brief Summary
Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metformin then metformin + vandetanib Vandetanib 800 mg Metformin alone followed by metformin in combination with vandetanib Metformin then metformin + vandetanib Metformin 1000 mg Metformin alone followed by metformin in combination with vandetanib
- Primary Outcome Measures
Name Time Method AUC for metformin administered alone and in combination with vandetanib 800 mg Period 1: Predose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post dose. Period 2: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post-dose. Cmax for metformin administered alone and in combination with vandetanib 800 mg Period 1: Predose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post dose. Period 2: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post-dose.
- Secondary Outcome Measures
Name Time Method Frequency and severity of adverse events Treatment period 7-14 days Laboratory data Treatment period 7-14 days Vital signs data Treatment period 7-14 days PK parameters for metformin in urine when administered alone and in combination with vandetanib Period 1: Day 1, 0 to 24 hrs and 24 to 48 hrs post metformin dose. Period 2: Day 1, 0 to 24 hrs and 24 to 48 hrs post metformin dose. ECG data Treatment period 7-14 days Vandetanib PK parameters for vandetanib in combination with metformin Period 2: pre-dose, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 36, 48, 72, 96, 168, 240, 336, 504, and 672 hours post-dose. Other PK parameters for metformin administered alone and in combination with vandetanib 800 mg Period 1: Predose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post dose. Period 2: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 32, 40, 48, 60, 72, and 96 hours post-dose.
Trial Locations
- Locations (1)
Research Site
🇺🇸Overland Park, Kansas, United States