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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin then metformin + vandetanib

Metformin alone followed by metformin in combination with vandetanib

Group Type EXPERIMENTAL

Metformin 1000 mg

Intervention Type DRUG

2 x 500 mg oral tablets

Vandetanib 800 mg

Intervention Type DRUG

2 x 300 mg and 2 x 100 mg oral tablets

Interventions

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Metformin 1000 mg

2 x 500 mg oral tablets

Intervention Type DRUG

Vandetanib 800 mg

2 x 300 mg and 2 x 100 mg oral tablets

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes