NCT01114152

Brief Summary

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

August 3, 2010

Status Verified

August 1, 2010

Enrollment Period

3 months

First QC Date

April 28, 2010

Last Update Submit

August 2, 2010

Conditions

Healthy

Keywords

AZD9742Japanese Healthy VolunteersPhase ISingle and Multiple Ascending Dose

Outcome Measures

Primary Outcomes (1)

  • Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)

    collected prior to treatment, during treatment and follow-up for a total of 18-22 days

Secondary Outcomes (1)

  • Characterize the Pharmacokinetics of AZD9742 in blood and urine

    PK-sampling during 14 pre-defined study days for PK profiling

Study Arms (2)

1

EXPERIMENTAL

Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8)

Drug: AZD9742

2

PLACEBO COMPARATOR

placebo given (2 subjects in each dose group)

Drug: Placebo

Interventions

AZD9742DRUG

IV Formulation

1
PlaceboDRUG

IV Formulation

2

Eligibility Criteria

Age23 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female (non-childbearing potential)
  • Body mass index (BMI) : 17 to 27 kg/m 2

You may not qualify if:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  • History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Glendale, California, United States

Location

Study Officials

  • Mark Yen, M..D.

    California Clinical Trials

    PRINCIPAL INVESTIGATOR

  • David Melnick

    AstraZeneca

    STUDY DIRECTOR

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

April 28, 2010

First Posted

April 30, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

August 3, 2010

Record last verified: 2010-08

Locations

US(1)