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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00690079
First received: June 2, 2008
Last updated: December 8, 2010
Last verified: January 2009

June 2, 2008
December 8, 2010
February 2008
October 2008   (final data collection date for primary outcome measure)
  • Safety AEs and vital signs [ Time Frame: During the whole study ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00690079 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Pain
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00690079
D5090C00008, EudraCT No. 2007-005470-31
No
Rolf Karlsten, MD, PhD Medical Science Director, AstraZeneca R&D Södertälje SE-151 85 Södertälje, Sweden
AstraZeneca
Not Provided
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
AstraZeneca
January 2009

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