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AZD7687 Multiple Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01119352
First received: May 6, 2010
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Overweight
Obese
Drug: AZD7687
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Genetic: Blood sampling at one occasion during the study. [ Time Frame: Once during study ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD7687
Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.
Placebo Comparator: 2 Drug: Placebo
Oral suspension, once daily. Totally 8 doses

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119352

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jan Eriksson AstraZeneca
Study Chair: Mirjana Kucajcic AstraZeneca
Principal Investigator: Darren Wilbraham Quintiles
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01119352     History of Changes
Other Study ID Numbers: D2710C00002, 2010-019112-21
Study First Received: May 6, 2010
Last Updated: January 18, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability
PK
healthy
overweight
obese

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014