A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01064388
Collaborator
(none)
36
1
2
5.9
6.1
Study Details
Study Description
Brief Summary
The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase I, Single Center, Double-blind Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Aug 1, 2010
Actual Study Completion Date
:
Aug 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: AZD9742
IV infusion, 15 days
|
| Placebo Comparator: 2
|
Drug: Placebo
IV infusion, 15 days
|
Outcome Measures
Primary Outcome Measures
- 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 25-30 days.]
Secondary Outcome Measures
- To characterize the Pharmacokinetics of AZD9742 in blood and urine [PK-sampling during 14 pre-defined study days for PK profiling]
Eligibility Criteria
Criteria
Ages Eligible for Study:
23 Years
to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- BMI between 19-30
Exclusion Criteria:
-
Positive Fecal Occult Blood Test
-
Prescriptions that inhibit liver function
-
Received flu/H1N1 vaccine within 2 weeks before first dose
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Overland Park | Kansas | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Andrew Shaw, AstraZeneca
- Study Chair: Brendan Smyth, AstraZeneca
- Study Director: David Melnick, AstraZeneca
- Principal Investigator: Ralph Schutz, Quintiles, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01064388
Other Study ID Numbers:
- D2690C00002
First Posted:
Feb 8, 2010
Last Update Posted:
Jun 6, 2012
Last Verified:
Jun 1, 2012
Keywords provided by AstraZeneca