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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD1386; Drug: Placebo for AZD1386; Drug: Naproxen; Drug: Placebo for Naproxen

• Registration Number: NCT00945178
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-17
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Start: 2009-08
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: A	AZD1386	AZD1386
Part A: B	Placebo for AZD1386	Placebo for AZD1386
Part B: A	Naproxen	Naproxen
Part B: B	Placebo for Naproxen	Placebo for Naproxen

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Research Site; 🇬🇧 Harrow, United Kingdom