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
  Purpose

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 Intervention Phase
Chronic Pain
Drug: AZD1386
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 69
Study Start Date: February 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 2, 2008
Last Updated: December 8, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 01, 2014