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Completed

NCT Number: NCT01037725

Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers

The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.

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Key information

Conditions

Healthy

Age range

18 year–45 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

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
  • Healthy male and female volunteers. Females must be of non childbearing potential

Exclusion criteria

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
  • History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Treatment and study plan

AZD5847

Drug

Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1.

Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal

Placebo to AZD5847

Drug

In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1

Primary outcomes

  1. Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals

    Time frame: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.

Secondary outcomes

  1. To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.

    Time frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose.

  2. To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847

    Time frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential

Important dates

Study start
2009
Study completion
2010
First posted
Dec 23, 2009
Registry last updated
Jul 14, 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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