CompletedNCT01551615VandetanibUpdated Aug 29, 2016

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

A Phase 1 interventional study of Metformin 1000 mg and Vandetanib 800 mg in Healthy, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-29.

Sponsored by Sanofi · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 14
Allocation: Not applicable
Ages: 18 Years to 50 Years
Sex: All

Study summary

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

Read the 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

Conditions studied

Healthy

Keywords

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

In context

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 14 participants (actual)

Study arms

Experimental
Metformin then metformin + vandetanib
Metformin alone followed by metformin in combination with vandetanib
Drug: Metformin 1000 mg · Drug: Vandetanib 800 mg

Interventions

DrugMetformin 1000 mg
2 x 500 mg oral tablets
DrugVandetanib 800 mg
2 x 300 mg and 2 x 100 mg oral tablets

What researchers measure

Primary outcomes

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 outcomes

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.

Study locations

1 site

Research Site
Overland Park, Kansas, United States

References and documents

Publications

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. PubMed 25117183 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2012, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 5, 2012
First posted: Mar 13, 2012
Start: Mar 2012
Primary completionActual: Jun 2012
CompletionActual: Jun 2012
Last update: Aug 29, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01551615
Lead sponsor: Sanofi
Responsible party: Sponsor
First posted: Mar 13, 2012
Start date: Mar 2012
Primary completion: Jun 2012
Completion: Jun 2012
Last update: Aug 29, 2016

Study contacts

Clinical Sciences & Operations

study director · Sanofi

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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