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

NCT00839683 | Completed Phase 1

• 1 other identifier: MB102-036
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs

  72 hours post-dose

Secondary Outcomes (3)

• To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects

  15 timepoints

• To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects

  15 timepoints

• To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects

  15 timepoints

Study Arms (5)

simvastatin

ACTIVE COMPARATOR

Drug: simvastatin

Dapagliflozin + simvastatin

ACTIVE COMPARATOR

Drug: Dapagliflozin; Drug: simvastatin

Dapagliflozin

ACTIVE COMPARATOR

Drug: Dapagliflozin

valsartan

ACTIVE COMPARATOR

Drug: valsartan

Dapagliflozin + valsartan

ACTIVE COMPARATOR

Drug: Dapagliflozin; Drug: valsartan

Interventions

simvastatin DRUG

Tablets, Oral, 20 mg, Single Dose

Also known as: Zocor

simvastatin

Dapagliflozin DRUG

Tablets, Oral, 20 mg, Single Dose

Also known as: BMS-512148

Dapagliflozin; Dapagliflozin + simvastatin; Dapagliflozin + valsartan

valsartan DRUG

Tablets, Oral, 320 mg, Single Dose

Also known as: Diovan

Dapagliflozin + valsartan; valsartan

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Mds Pharma Services (Us) Inc.

Neptune City, New Jersey, 07753, United States

Location

Related Links

• MB102-036\_redacted \_CSR \_synopsis

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Simvastatin; dapagliflozin; Valsartan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 9, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

US (1)