Clinical trial NCT01176097: To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
Official title: A Randomized, Single-Blind, Placebo-Controlled, Single-Center, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Fasting After Single Ascending Oral Doses of AZD5658 in Type 2 Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: First in man study evaluating AZD5658 in Type 2 Diabetics.
Effect of fasting
Safety
Tolerability
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

Detailed description: This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Eligibility criteria: Inclusion Criteria:

* Patients must be of non-childbearing potential.
* Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
* Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
* Participation in another clinical study during the last 30 days prior to enrollment
* Significant cardiovascular event within the last 6 months prior to enrollment

Primary outcomes:
measure: To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).
timeFrame: AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3
Secondary outcomes:
measure: To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.
timeFrame: Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose
measure: Pharmacodynamics (plasma glucose and serum insulin)
timeFrame: Plasma glucose and serum insulin determined on Day -1 through Day 4
measure: Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&DPepparedsleden 1431 83 M�lnda
name: Karin Wahlander
role: STUDY_DIRECTOR
affiliation: AstraZeneca R&DPepparedsleden 1431 83 M�lndal
name: Mirjana Kujacic
role: STUDY_CHAIR
affiliation: Profil Institute for Clinical Research, Inc.855 Third Avenue, Suite 4400Chula Vista, CA 91911
name: Linda Morrow
role: PRINCIPAL_INVESTIGATOR
References: