NCT01551615

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

March 5, 2012

Last Update Submit

August 26, 2016

Conditions

Healthy

Keywords

Phase 1healthy volunteerspharmacokineticsvandetanibmetforminAUC(0-t)t1/2tmaxCL/FVz/FCmax

Outcome Measures

Primary Outcomes (2)

  • AUC for metformin administered alone and in combination with vandetanib 800 mg

    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

    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 Outcomes (7)

  • Frequency and severity of adverse events

    Treatment period 7-14 days

  • ECG data

    Treatment period 7-14 days

  • Laboratory data

    Treatment period 7-14 days

  • Vital signs data

    Treatment period 7-14 days

  • Other PK parameters for metformin administered alone and in combination with vandetanib 800 mg

    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.

  • +2 more secondary outcomes

Study Arms (1)

Metformin then metformin + vandetanib

EXPERIMENTAL

Metformin alone followed by metformin in combination with vandetanib

Drug: Metformin 1000 mgDrug: Vandetanib 800 mg

Interventions

Metformin 1000 mgDRUG

2 x 500 mg oral tablets

Metformin then metformin + vandetanib
Vandetanib 800 mgDRUG

2 x 300 mg and 2 x 100 mg oral tablets

Metformin then metformin + vandetanib

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • Johansson S, Read J, Oliver S, Steinberg M, Li Y, Lisbon E, Mathews D, Leese PT, Martin P. Pharmacokinetic evaluations of the co-administrations of vandetanib and metformin, digoxin, midazolam, omeprazole or ranitidine. Clin Pharmacokinet. 2014 Sep;53(9):837-47. doi: 10.1007/s40262-014-0161-2.

    PMID: 25117183DERIVED

Related Links

MeSH Terms

Interventions

Metforminvandetanib

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

US(1)