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

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ClinicalTrials.gov Identifier: NCT00690079
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: AZD1386 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : February 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AZD1386
7 groups receiving a specified volume of the active component AZD1386 at different points of time.
Drug: AZD1386
Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L
Placebo Comparator: Placebo
7 groups receiving a specified volume of placebo at different points of time
Drug: Placebo
Oral admin. of doses at 11 days through a 12 days period.



Primary Outcome Measures :
  1. Safety AEs and vital signs [ Time Frame: During the whole study ]
  2. 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT00690079


Locations
United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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

Responsible Party: Rolf Karlsten, MD, PhD Medical Science Director, AstraZeneca R&D Södertälje SE-151 85 Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00690079     History of Changes
Other Study ID Numbers: D5090C00008
EudraCT No. 2007-005470-31
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: January 2009

Keywords provided by AstraZeneca:
MAD
Multiple ascending dose
Chronic pain
pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms