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AZD7687 Multiple Ascending Dose Study

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ClinicalTrials.gov Identifier: NCT01119352
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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

Condition or disease Intervention/treatment Phase
Overweight Obese Drug: AZD7687 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : April 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01119352     History of Changes
Other Study ID Numbers: D2710C00002
2010-019112-21 ( EudraCT Number )
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
Safety
tolerability
PK
healthy
overweight
obese

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms