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A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01064388
Enrollment
36
Registered
2010-02-08
Start date
2010-02-28
Completion date
2010-08-31
Last updated
2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety

Brief summary

The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.

Interventions

IV infusion, 15 days

DRUGPlacebo

IV infusion, 15 days

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
23 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To characterize the Pharmacokinetics of AZD9742 in blood and urinePK-sampling during 14 pre-defined study days for PK profiling

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026