Skip to main content
OpenTrials
Completed

NCT Number: NCT00690079

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Macclesfield, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1386

Drug

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

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Acronym: MAD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 4, 2008
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.