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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551615
First Posted: March 13, 2012
Last Update Posted: August 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose
Study in Healthy Volunteers to Assess the Pharmacokinetics of Metformin Administered Alone and In Combination with Vandetanib

Condition Intervention Phase
Healthy Drug: Metformin 1000 mg Drug: Vandetanib 800 mg Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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. ]
  • 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. ]

Secondary Outcome Measures:
  • Frequency and severity of adverse events [ Time Frame: Treatment period 7-14 days ]
  • ECG data [ Time Frame: Treatment period 7-14 days ]
  • Laboratory data [ Time Frame: Treatment period 7-14 days ]
  • Vital signs data [ Time Frame: Treatment period 7-14 days ]
  • 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. ]
  • 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. ]
  • 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. ]

Enrollment: 14
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin then metformin + vandetanib
Metformin alone followed by metformin in combination with vandetanib
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551615


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01551615     History of Changes
Other Study ID Numbers: D4200C00102
First Submitted: March 5, 2012
First Posted: March 13, 2012
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by Sanofi:
Phase 1
healthy volunteers
pharmacokinetics
vandetanib
metformin
AUC(0-t)
t1/2
tmax
CL/F
Vz/F
Cmax

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs