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Completed

NCT Number: NCT00681317

AZD6280 Multiple Ascending Dose Study

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subjects must be of non-child bearing potential.

Exclusion criteria

  • Clinically significant illness within 2 weeks before the study start.
  • Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
  • Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Treatment and study plan

AZD6280

Drug

oral

Primary outcomes

  1. To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs

    Time frame: Assessments are made at each visit, at least daily, during the study.

Secondary outcomes

  1. Evaluation and characterization of the pharmacokinetics of AZD6280

    Time frame: Blood samples will be taken during the study.

  2. Evaluation of the pharmacodynamic effects of AZD6280

    Time frame: Test batteries will be performed at specified times both before and following study drug administration

  3. Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6280.

    Time frame: A single blood sample will be obtained.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential

Acronym: MAD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 21, 2008
Registry last updated
Dec 9, 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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