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

NCT00945178 | Terminated Phase 1 DMC

• 2 other identifiers: D5090C00021EudraCT No.: 2009-012114-43
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Safety; Tolerability; Healthy; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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).

Study Arms (4)

Part A: A

EXPERIMENTAL

AZD1386

Drug: AZD1386

Part A: B

EXPERIMENTAL

Placebo for AZD1386

Drug: Placebo for AZD1386

Part B: A

EXPERIMENTAL

Naproxen

Drug: Naproxen

Part B: B

EXPERIMENTAL

Placebo for Naproxen

Drug: Placebo for Naproxen

Interventions

AZD1386 DRUG

Single ascending and multiple (twice daily) oral doses, capsule

Part A: A

Placebo for AZD1386 DRUG

Single ascending and multiple (twice daily) oral doses, capsule

Part A: B

Naproxen DRUG

Tablet, single oral dose, 500mg

Part B: A

Placebo for Naproxen DRUG

Tablet, single oral dose

Part B: B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Harrow, United Kingdom

Location

MeSH Terms

Interventions

AZD1386; Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Richard Leff

  AstraZeneca Pharmaceuticals, Wilmington, UK

  STUDY DIRECTOR

• Dr. Tania Hugo

  PAREXEL Early Phase Clinical Unit, London UK.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 24, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 10, 2010

Record last verified: 2009-12

Locations

GB (1)