Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Study identifier:MB102-036

ClinicalTrials.gov identifier:NCT00839683

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

simvastatin, Dapagliflozin, valsartan

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Feb 2009

Primary Completion Date: 01 Mar 2009

Study Completion Date: 01 Mar 2009

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Bristol-Myers Squibb

Inclusion and exclusion criteria

Inclusion Criteria

- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/[height (m)]2

Exclusion Criteria

- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
- Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
- Glucosuria at screening
- Abnormal liver functions tests (ALT, AST or total bilirubin > 10% above ULN)
- Presence of edema on physical exam
- History of diabetes mellitus
- History of heart failure
- History of renal insufficiency
- History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
- History of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections
- Positive urine screen for drugs of abuse either at screening or before dosing
- Positive blood screen for hepatitis C antibody, hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
- History of allergy to SGLT2 inhibitors or related compounds
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History of allergy or intolerance to valsartan or simvastatin (or related compounds)
- Prior exposure to dapagliflozin, valsartan or simvastatin within 3 months of Day -1
- Exposure to any investigational drug or placebo within 4 weeks of Day -1
- Use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to any study drug administration
- Use of any other drugs, including over-the counter medications within 1 week and herbal preparations within 2 weeks prior to admission to the study facility
- Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of Day -1

Location

Mds Pharma Services (Us) Inc.

Neptune, NJ, United States, 07753

Arms	Assigned Interventions
Active Comparator: simvastatin	Drug: simvastatin Tablets, Oral, 20 mg, Single Dose Other Name: Zocor
Active Comparator: Dapagliflozin + simvastatin	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: simvastatin Oral, 40 mg, Single Dose
Active Comparator: Dapagliflozin	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148
Active Comparator: valsartan	Drug: valsartan Tablets, Oral, 320 mg, Single Dose Other Name: Diovan
Active Comparator: Dapagliflozin + valsartan	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: valsartan Tablets, Oral, 320 mg, Single Dose Other Name: Diovan

"There is no result for the study"

Documents available

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Download
MB102-036_redacted _CSR _synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Contact Backup

First line of email MUST contain NCT# & Site#. Only trial are recruiting have contact information at this time.

Investigators

Principal Investigator

Bristol-Myers Squibb

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Mds Pharma Services (Us) Inc.

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

MB102-036_redacted _CSR _synopsis

Trial Results Summaries