NCT00769899

Brief Summary

This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

October 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

Enrollment Period

5 months

First QC Date

October 8, 2008

Last Update Submit

March 17, 2009

Conditions

Healthy Volunteer

Keywords

AZD7325Japanese Healthy VolunteersPhase I studySingle Ascending Dose

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments.

    During the study

Secondary Outcomes (2)

  • Pharmacokinetic parameters for AZD7325

    During residential period

  • Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects.

    During the study

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD7325

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD7325DRUG

Capsule for oral, single dose

1
PlaceboDRUG

Placebo capsule for oral, single dose

2

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) : 18 to 27 kg/m 2

You may not qualify if:

  • Clinically relevant disease and/or abnormalities (past or present)
  • Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
  • Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day)
  • Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

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

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamide

Study Officials

  • Mark Yen, MD

    California Clinical Trials

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 18, 2009

Record last verified: 2009-03

Locations

US(2)