Clinical trial NCT01083212: To Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
Official title: A Randomised, Open, Placebo Controlled, Two-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Effect of Gemfibrozil on the Pharmacokinetics and Pharmacodynamics of a Single Dose of AZD1656
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Gemfibrozil
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: PK of AZD1656 when administered with placebo or following repeated dosing of gemfibrozil by assessment of AUC and Cmax.
timeFrame: 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:
measure: 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
timeFrame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.
measure: 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
timeFrame: Serial blood samples will be drawn on day 4-6 period 1 and 2 from pre-dose to 48 h post AZD1656 administration.
measure: 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
timeFrame: 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.
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Reserach Site
city: Lulea
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Stanko Skrtic
role: STUDY_DIRECTOR
affiliation: Quintiles Hermelinen AB
name: Aslak Rautio
role: PRINCIPAL_INVESTIGATOR
affiliation: Quintiles AB
name: Wolfgang Kuhn
role: PRINCIPAL_INVESTIGATOR
affiliation: J.J. Berzelius Clinical Research Center AB
name: Folke Sjöberg
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Mirjana Kujacic
role: STUDY_CHAIR
References: