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

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

Overview[ - collapse ][ - ]

Purpose	Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib
Condition	Healthy
Intervention	Drug: Metformin 1000 mg Drug: Vandetanib 800 mg
Phase	Phase 1
Sponsor	AstraZeneca
Responsible Party	AstraZeneca
ClinicalTrials.gov Identifier	NCT01551615
First Received	March 5, 2012
Last Updated	June 22, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	March 5, 2012
Last Updated Date	June 22, 2012
Start Date	March 2012
Estimated Primary Completion Date	June 2012
Current Primary Outcome Measures	AUC for metformin administered alone and in combination with vandetanib 800 mg [Time Frame: 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.] [Designated as safety issue: No] Cmax for metformin administered alone and in combination with vandetanib 800 mg [Time Frame: 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.] [Designated as safety issue: No]
Current Secondary Outcome Measures	Frequency and severity of adverse events [Time Frame: Treatment period 7-14 days] [Designated as safety issue: Yes] ECG data [Time Frame: Treatment period 7-14 days] [Designated as safety issue: Yes] Laboratory data [Time Frame: Treatment period 7-14 days] [Designated as safety issue: Yes] Vital signs data [Time Frame: Treatment period 7-14 days] [Designated as safety issue: Yes] Other PK parameters for metformin administered alone and in combination with vandetanib 800 mg [Time Frame: 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.] [Designated as safety issue: No] Vandetanib PK parameters for vandetanib in combination with metformin [Time Frame: 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.] [Designated as safety issue: No] PK parameters for metformin in urine when administered alone and in combination with vandetanib [Time Frame: 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.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Phase I Study to Assess the Pharmacokinetics of Metformin When Administered Alone and in Combination With Vandetanib
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
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
Study Type	Interventional
Study Phase	Phase 1
Study Design	Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Healthy
Intervention	Drug: Metformin 1000 mg 2 x 500 mg oral tablets Drug: Vandetanib 800 mg 2 x 300 mg and 2 x 100 mg oral tablets
Study Arm (s)	Experimental: Metformin then metformin + vandetanib Metformin alone followed by metformin in combination with vandetanib

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	14
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012
Eligibility 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).
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01551615
Other Study ID Numbers	D4200C00102
Has Data Monitoring Committee	Not Provided
Information Provided By	AstraZeneca
Study Sponsor	AstraZeneca
Collaborators	Not Provided
Investigators	Study Director: James Vaselli, Medical Science Director AstraZenecaPrincipal Investigator: David Mathews, MD Quintiles
Verification Date	June 2012

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