Skip to main content
OpenTrials
Completed

NCT Number: NCT01119352

AZD7687 Multiple Ascending Dose Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD7687

Drug

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

Placebo

Drug

Oral suspension, once daily. Totally 8 doses

Primary outcomes

  1. Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)

    Time frame: Before, during and after dosing.

Secondary outcomes

  1. Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters

    Time frame: Information will be collected from the time of day -2 throughout the study.

  2. Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)

    Time frame: Information will be collected from the time of day -2 throughout the study.

  3. Genetic: Blood sampling at one occasion during the study.

    Time frame: Once during study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 7, 2010
Registry last updated
Jan 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.