Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

NCT ID: NCT01546558

Last Updated: 2012-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-03-31

Brief Summary

The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus (T2DM).

Detailed Description

The primary objective of this study is as follows:

• To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady state pharmacokinetics (PK) of metformin in subjects with T2DM.

The secondary objectives of this study are as follows:

• To examine the safety and tolerability of metformin when co administered with ranolazine 500 mg bid at steady-state in subjects with T2DM.
• To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM receiving metformin.

Conditions

Type 2 Diabetes Mellitus

Keywords

Metformin; Ranolazine; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Metformin, Ranolazine

Single cohort, 2-period study:

• Period 1, metformin 1000 mg bid on Days 1-5
• Period 2, metformin 1000 mg bid + ranolazine 500 mg bid on Days 6-10

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 1000 mg bid on Days 1-10

Ranolazine

Intervention Type: DRUG

Ranolazine 500 mg bid on Days 6-10

Interventions

Metformin

Metformin 1000 mg bid on Days 1-10

Intervention Type: DRUG

Ranolazine

Ranolazine 500 mg bid on Days 6-10

Intervention Type: DRUG

Other Intervention Names

Glucophage; Ranexa

Eligibility Criteria

Inclusion Criteria

• Males and females, 30 to 65 years old, inclusive
• Documented history of T2DM
• HbA1c 6.5%-10%, inclusive
• Fasting serum glucose ≤ 270 mg/dL at Screening
• Fasting C-peptide ≥ 1 ng/mL at Screening
• Stable metformin monotherapy (metformin ≥ 1500 mg total daily dose for at least 4 weeks prior to Screening)
• Body mass index (BMI) 25 to 40 kg/m2, inclusive, at Screening
• Creatinine Clearance > 80 mL/min at Screening
• Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug

Exclusion Criteria

• Type 1 Diabetes Mellitus (T1DM)
• Use of insulin therapy < 3 months prior to Screening
• History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
• Clinically significant complications of diabetes
• History of hypoglycemia
• Any non-insulin antidiabetic therapy (other than metformin) < 2 months prior to Screening
• Any clinically significant cardiovascular event < 2 months prior to Screening
• Clinically significant, inadequately controlled, or unstable hypertension
• Hospitalization < 2 months prior to Screening or major surgery < 3 months prior to Screening
• History of gastrointestinal disease or surgery that could impact drug absorption
• History of substance of alcohol or substance abuse
• Positive urine drug screen for drugs of abuse
• Positive alcohol breath test
• Any other clinically significant existing medical or psychiatric condition or one requiring further evaluation
• Treatment with selected medications
• Hemoglobin < 12 g/dL for males; or < 11 g/dL for females at Screening
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5x upper limits of normal
• Clinically significant history of hepatic disease or evidence of hepatic impairment
• Positive blood screen for hepatitis C or hepatitis B
• QTc interval > 500 msec at Screening
• Females who are pregnant or are breastfeeding

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Juan, MD

Role: PRINCIPAL_INVESTIGATOR

SeaView Research, Inc.

Locations

SeaView Research Inc.

Miami, Florida, United States

Countries

United States

Other Identifiers

GS-US-259-0143

Identifier Type: -

Identifier Source: org_study_id