A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Metformin 1000 mg (Drug); Vandetanib 800 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): James Vaselli, Medical Science Director, Study Director, Affiliation: AstraZeneca David Mathews, MD, Principal Investigator, Affiliation: Quintiles
Summary
Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone
and In Combination with Vandetanib
Clinical Details
Official title: 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
Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: AUC for metformin administered alone and in combination with vandetanib 800 mgCmax for metformin administered alone and in combination with vandetanib 800 mg
Secondary outcome: Frequency and severity of adverse eventsECG data Laboratory data Vital signs data Other PK parameters for metformin administered alone and in combination with vandetanib 800 mg Vandetanib PK parameters for vandetanib in combination with metformin PK parameters for metformin in urine when 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
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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).
Locations and Contacts
Research Site, Overland Park, Kansas, United States
Additional Information
CSR-D4200C00102.pdf Revised_CSP_redacted
Starting date: March 2012
Last updated: August 14, 2014
|