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Trial record 84 of 914 for:    tablet | Japan

Investigate the Safety Tolerability and Pharmacokinetics of Multiple Doses of AZD1236

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ClinicalTrials.gov Identifier: NCT00767052
Recruitment Status : Completed
First Posted : October 6, 2008
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of multiple ascending oral doses of AZD1236 given to healthy young subjects for 13 days and to evaluate the single-dose relative bioavailability of the oral suspension and oral tablet formulations.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AZD1236 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Randomised Single Centre Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral Multiple Ascending Daily Doses of AZD1236 Tablet by a Single-Blind, Placebo-Controlled, and Single Dose Relative Bioavailability of the Oral Suspension and Oral Tablet Formulations by an Open Cross-Over in Healthy Japanese Men
Study Start Date : September 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Active
AZD1236 tablet
Drug: AZD1236
75mg once daily or 75mg twice daily will be administered in multiple dose part.

Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo
Placebo tablet matching to the active in multiple dose part.

Relative bioavailability
AZD1236 Oral suspension
Drug: AZD1236
75mg single dose will be administered in relative bioavailability part.

Relative bioavailability tablet
AZD1236 tablet
Drug: AZD1236
75mg oral suspension single dose will be administered in relative bioavailability part.




Primary Outcome Measures :
  1. Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events [ Time Frame: Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events. ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile: concentration of AZD1236 in blood [ Time Frame: Samples taken during Visit 2 in multiple dosing part at 41 points and Visit 2/3 in relative bioavailability part at 32 points. ]


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:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed informed consent prior to any study specific procedures
  • Body Mass Index (BMI) between 19-27 kg/m2

Exclusion Criteria:

  • Receipt of another investigational drug in the 4 months before dosing in this study
  • Acute illness which requires medical intervention within 2 weeks of Visit 2.
  • Abnormal resting BP and pulse rate (after resting for 10 minutes). Supine blood pressure > 140 mmHg systolic or >90 mmHg diastolic, pulse<= 50 or => 90 beats per minute

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): NCT00767052


Locations
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Japan
Research Site
Osaka-city, Osaka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Shunji Matsuki, MD PhD Kyushu Clinical Pharmacology Research Clinic

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Responsible Party: J Andrew Lockton MRCP(UK) MD FFPM, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00767052     History of Changes
Other Study ID Numbers: D4260C00006
First Posted: October 6, 2008    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Healthy Volunteer
Safety
Tolerability
Pharmacokinetics
AZD1236