NCT00957437

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

November 26, 2009

Status Verified

November 1, 2009

First QC Date

August 10, 2009

Last Update Submit

November 25, 2009

Conditions

Healthy

Keywords

Phase 1healthy volunteermalepharmacokineticsAZD1305

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma

    From predose until 48 hours post last dose

Secondary Outcomes (1)

  • Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight

    Frequent safety measurements during the study, from screening period to follow-up

Study Arms (3)

Part A: 3 way crossover

EXPERIMENTAL

AZD1305: ER test formulation 1 (w/wo food) and reference formulation

Drug: AZD1305

Part B1: single arm

EXPERIMENTAL

AZD1305: ER test formulation 1

Drug: AZD1305

Part B2: 3 way crossover

EXPERIMENTAL

AZD1305: ER test formulation 2 (w/wo food) and reference formulation

Drug: AZD1305

Interventions

AZD1305DRUG

Single Oral Dose, ER formulation 1

Part A: 3 way crossover

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed, written and dated informed consent prior to any study specific procedures.
  • Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg.

You may not qualify if:

  • History or presence of any clinically significant disease or disorder in the opinion of the investigator.
  • Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit.
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Harrow, United Kingdom

Location

MeSH Terms

Interventions

tert-butyl (2-(7-(2-(4-cyano-2-fluorophenoxy)ethyl)-9-oxa-3,7-diazabicyclo(3.3.1)non3-yl)ethyl)carbamate

Study Officials

  • Helen Lunde

    AstraZeneca R&D, Mölndal, Sweden

    STUDY DIRECTOR

  • Klaus Francke

    PAREXEL Early Phase Clinical Unit, London UK.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 12, 2009

Study Start

August 1, 2009

Study Completion

November 1, 2009

Last Updated

November 26, 2009

Record last verified: 2009-11

Locations

GB(1)