To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

NCT01083212 | Completed Phase 1

• 1 other identifier: D1020C00030
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Gemfibrozil

Outcome Measures

Primary Outcomes (1)

• PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax.

  Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.

Secondary Outcomes (3)

• PK of AZD1656 when administered with placebo or following repeated dosing of germfibrozil by assessment of AUC0-t, tmax, t1/2, CL/F and Vz/F

  Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.

• PK of AZD1656 metabolite, when AZD1656 is administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC, AUC0-t, Cmax, tmax, t1/2

  Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.

• Safety of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables including 24-h plasma glucose, physical examination and adverse events

  Paper ECG, BP/pulse preentry, pre-dose,day 4, period 1 and 2, and follow-up on day +7-10 days. Weight, physical examination preentry and pre-dose (period 1 and 2), follow-up. 7-point plasma-glucose on pre-entry, day 3 and 5, period 1 and 2.

Study Arms (2)

1

EXPERIMENTAL

Gemfibrozil day 1-5 + AZD1656 day 4, 1 week without, Placebo day 1-5 + AZD1656 day 4

Drug: AZD1656; Drug: Gemfibrozil; Drug: Placebo

2

EXPERIMENTAL

Placebo day 1-5 + AZD1656 day 4, 1 week without, Gemfibrozil day 1-5 + AZD1656 day 4

Drug: AZD1656; Drug: Gemfibrozil; Drug: Placebo

Interventions

AZD1656 DRUG

Single dose,oral tablet

1; 2

Gemfibrozil DRUG

Oral tablet bid on day 1 - 5.

1; 2

Placebo DRUG

Oral tablet bid on day 1-5

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed Type 2 diabetes mellitus for at least 1 year and treated with metformin.
• Body mass index between ≥19 and ≤42 kg/m2.

You may not qualify if:

• Intake of another investigational drug within the last 30 days prior to enrolment.
• Clinically significant illness or clinically relevant trauma.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Reserach Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

AZD1656; Gemfibrozil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Pentanoic Acids; Valerates; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Stanko Skrtic

  AstraZeneca

  STUDY DIRECTOR

• Aslak Rautio

  Quintiles Hermelinen AB

  PRINCIPAL INVESTIGATOR

• Wolfgang Kuhn

  Quintiles AB

  PRINCIPAL INVESTIGATOR

• Folke Sjöberg

  J.J. Berzelius Clinical Research Center AB

  PRINCIPAL INVESTIGATOR

• Mirjana Kujacic

  AstraZeneca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 1, 2010

Record last verified: 2010-06

Locations

SE (3)