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

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ClinicalTrials.gov Identifier: NCT00945178
Recruitment Status : Terminated (The study was terminated due to results in another study (NCT00878501).)
First Posted : July 24, 2009
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Volunteers Drug: AZD1386 Drug: Placebo for AZD1386 Drug: Naproxen Drug: Placebo for Naproxen Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Naproxen

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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). ]


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, 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.

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): NCT00945178


Locations
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United Kingdom
Research Site
Harrow, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Richard Leff AstraZeneca Pharmaceuticals, Wilmington, UK
Principal Investigator: Dr. Tania Hugo PAREXEL Early Phase Clinical Unit, London UK.
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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00945178    
Other Study ID Numbers: D5090C00021
EudraCT No.: 2009-012114-43
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2009
Keywords provided by AstraZeneca:
Safety
Tolerability
Healthy
Pharmacokinetics
Additional relevant MeSH terms:
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Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action