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Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

This study has been terminated.
(The study was terminated due to results in another study (NCT00878501).)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00945178
First received: July 17, 2009
Last updated: December 8, 2010
Last verified: December 2009
History of Changes
  Purpose

The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.


Condition Intervention Phase
Healthy Volunteers
 Drug: AZD1386
Drug: Placebo for AZD1386
Drug: Naproxen
Drug: Placebo for Naproxen
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Two-part Study to Assess Safety, Tolerability, Pharmacokinetics of Orally Administered AZD1386

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (adverse events, vital signs, ECG, safety lab) [ Time Frame: Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2) and at follow-up 4-14 days after discharge. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD1386 in plasma [ Time Frame: Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2). ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: August 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: A
AZD1386
 Drug: AZD1386
Single ascending and multiple (twice daily) oral doses, capsule
Experimental: Part A: B
Placebo for AZD1386
 Drug: Placebo for AZD1386
Single ascending and multiple (twice daily) oral doses, capsule
Experimental: Part B: A
Naproxen
 Drug: Naproxen
Tablet, single oral dose, 500mg
Experimental: Part B: B
Placebo for Naproxen
 Drug: Placebo for Naproxen
Tablet, single oral dose

  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, written and dated informed consent prior to any study specific procedures
  • Healthy male and female (of non childbearing potential)
  • Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and a weight of ≥50 to ≤100 kg

Exclusion Criteria:

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945178

Locations
United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Richard Leff AstraZeneca Pharmaceuticals, Wilmington, UK
Principal Investigator: Dr. Tania Hugo PAREXEL Early Phase Clinical Unit, London UK.
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00945178     History of Changes
Other Study ID Numbers: D5090C00021, EudraCT No.: 2009-012114-43
Study First Received: July 17, 2009
Last Updated: December 8, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
Tolerability
Healthy
Pharmacokinetics

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013