Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Single-centre, Randomised, Double-blind, Placebo-controlled, Two-part Study to Assess Safety, Tolerability, Pharmacokinetics of Orally Administered AZD1386

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00945178
• Other study ID #: D5090C00021
• Secondary ID: EudraCT No.: 200
• Status: Terminated
• Phase: Phase 1
• First received: July 17, 2009
• Last updated: December 8, 2010
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of signed, written and dated informed consent prior to any study specific procedures

• Healthy male and female (of non childbearing potential)

• Body Mass Index (BMI) of =19 to =28 kg/m2 and a weight of =50 to =100 kg

Exclusion Criteria:

• History or presence of any clinically significant disease or disorder in the opinion of the investigator.

• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD1386
Single ascending and multiple (twice daily) oral doses, capsule
• Placebo for AZD1386
Single ascending and multiple (twice daily) oral doses, capsule
• Naproxen
Tablet, single oral dose, 500mg
• Placebo for Naproxen
Tablet, single oral dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (adverse events, vital signs, ECG, safety lab)		Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2) and at follow-up 4-14 days after discharge.	Yes
Secondary	To characterize the pharmacokinetics of AZD1386 in plasma		Assessments performed at frequent timepoints (predose then ranging from 15 minutes to every 12 hours) on Days -1 to Day 3 (Part A: treatment period 1 and Part B) or Day-1 to Day 9 (Part A: treatment period 2).	No