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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 mg

Cmax for metformin administered alone and in combination with vandetanib 800 mg

Secondary outcome:

Frequency and severity of adverse events

ECG 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

Page last updated: August 23, 2015

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