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Completed

NCT Number: NCT01116258

A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Overland Park, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 18-30

Exclusion criteria

  • Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
  • History of presence of gastrointestinal, hepatic or renal disease

Treatment and study plan

AZD5847

Drug

oral suspension, 15 days

Placebo

Drug

oral suspension, 15 days

Primary outcomes

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

    Time frame: collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening)

Secondary outcomes

  1. characterize the Pharmacokinetics of AZD9742 in blood and urine

    Time frame: PK-sampling during 14 pre-defined study days for PK profiling

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects of Non-childbearing Potential

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 4, 2010
Registry last updated
Oct 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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