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Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386 (MAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00690079
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE June 2, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date December 10, 2010
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
  • Safety AEs and vital signs [ Time Frame: During the whole study ]
  • ECG-recordings [ Time Frame: ECGs (5 minutes) Days 1 and 12. 2 ECGs (5 minutes) Days 3, 6 and 10. 1 ECG (5 minutes) Days 2 and 13. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00690079 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
PK [ Time Frame: Days 1, 5 and 12, 12 times each day. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
PK [ Time Frame: Days 1, 5 and 12, 12 times totally. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386
Official Title  ICMJE A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian Young and Elderly Subjects After Oral Multiple Doses.
Brief Summary The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: AZD1386
    Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L
  • Drug: Placebo
    Oral admin. of doses at 11 days through a 12 days period.
Study Arms  ICMJE
  • Experimental: AZD1386
    7 groups receiving a specified volume of the active component AZD1386 at different points of time.
    Intervention: Drug: AZD1386
  • Placebo Comparator: Placebo
    7 groups receiving a specified volume of placebo at different points of time
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 27, 2008)
69
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
61
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
  • Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg
  • Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria:

  • History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study.
  • History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
  • Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690079
Other Study ID Numbers  ICMJE D5090C00008
EudraCT No. 2007-005470-31
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rolf Karlsten, MD, PhD Medical Science Director, AstraZeneca R&D Södertälje SE-151 85 Södertälje, Sweden
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rolf Karlsten Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Ray Chetty AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG
PRS Account AstraZeneca
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP