NCT00935025

Brief Summary

This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

2 active sites

Status
terminated

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

July 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

December 7, 2010

Status Verified

December 1, 2010

Enrollment Period

4 months

First QC Date

July 2, 2009

Last Update Submit

December 6, 2010

Conditions

Healthy

Keywords

Phase IJapanese healthy volunteerAZD1305Japanese and Caucasian

Outcome Measures

Primary Outcomes (1)

  • Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight

    During the study, from screening period to follow-up, 50 days approximately

Secondary Outcomes (1)

  • Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses

    From predose until 48 hrs post last dose

Study Arms (2)

1, AZD1305

EXPERIMENTAL
Drug: AZD1305

2, Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1305DRUG

single and multiple oral doses, extended-release capsule

1, AZD1305
PlaceboDRUG

single and multiple oral doses, capsule

2, Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive
  • Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2

You may not qualify if:

  • Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator
  • History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator
  • Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Glendale, California, United States

Location

Research Site

Baltimore, Maryland, United States

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

  • Mark Yen, M.D.

    California Clinical Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 8, 2009

Study Start

July 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

December 7, 2010

Record last verified: 2010-12

Locations

US(2)