Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

NCT00690079 | Completed Phase 1

• 2 other identifiers: D5090C00008EudraCT No. 2007-005470-31
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

MAD; Multiple ascending dose; Chronic pain; pain

Outcome Measures

Primary Outcomes (2)

• Safety AEs and vital signs

  During the whole study

• ECG-recordings

  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 Outcomes (1)

• PK

  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.

Study Arms (2)

AZD1386

EXPERIMENTAL

7 groups receiving a specified volume of the active component AZD1386 at different points of time.

Drug: AZD1386

Placebo

PLACEBO COMPARATOR

7 groups receiving a specified volume of placebo at different points of time

Drug: Placebo

Interventions

AZD1386 DRUG

Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol\*h/L

AZD1386

Placebo DRUG

Oral admin. of doses at 11 days through a 12 days period.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Macclesfield, Cheshire, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Pain

Interventions

AZD1386

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Karlsten

  Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

  STUDY DIRECTOR

• Ray Chetty

  AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 4, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 10, 2010

Record last verified: 2009-01

Locations

GB (1)