AZD7687 Multiple Ascending Dose Study

Overweight Clinical Trial

Official title:

A Phase 1, Single Centre, Single-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Multiple Ascending Doses in Overweight to Obese But Otherwise Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119352
• Other study ID #: D2710C00002
• Secondary ID: 2010-019112-21
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2010
• Last updated: January 18, 2012
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures

• suitable veins for cannulation or repeated venepuncture.

• Have a body mass index (BMI) between 27 and 35 kg/m2

Exclusion Criteria:

• Fasting serum (S)-glucose =7.0 mmol/L or non-fasting S-glucose =11.1 mmol/L at screening.

• Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment.

• Smoking more than 7 cigarettes per week from time of consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

Drug:
• AZD7687
Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.
• Placebo
Oral suspension, once daily. Totally 8 doses

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)		Before, during and after dosing.	Yes
Secondary	Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters		Information will be collected from the time of day -2 throughout the study.	No
Secondary	Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)		Information will be collected from the time of day -2 throughout the study.	No
Secondary	Genetic: Blood sampling at one occasion during the study.		Once during study	No