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Completed

NCT Number: NCT00832169

Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386

The aim of this study is to get information about absorption, distribution, metabolism and excretion as well as the tolerability and safety of AZD1386 in healthy male volunteers.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Macclesfield, CHESHIRE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index of 18 - 30 and weight of 50 to 100 kilos.
  • Healthy volunteer must have regular bowel movements (at least once daily)

Exclusion criteria

  • History of psychiatric or somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator.
  • A family history of short QT syndrome or sudden cardiac death amongst first degree relatives.
  • Any clinically important abnormalities in heart rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Treatment and study plan

AZD1386

Drug

1 dose of oral solution

Primary outcomes

  1. Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386

    Time frame: Until >90% of predicted total radioactivity has been recovered

  2. Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta

    Time frame: Predose, + postdose 0.5h, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144hPredose + postdose 1h, 4h, 8h, 24h for excreta from predose (baseline) + postdose from 0h continously until 144h

Secondary outcomes

  1. AZD1386 metabolites in plasma+excreta if feasable

    Time frame: Predose, 1h, 4h, 8h 24h

  2. Safety + tolerability of AZD1386

    Time frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Single Dose, Phase I Study of the Excretion of Radioactivity, Metabolism and Pharmacokinetics Following Oral Administration of [14C]AZD1386 to Healthy Male Volunteers

Important dates

Study start
2009
Study completion
2009
First posted
Jan 30, 2009
Registry last updated
Apr 28, 2009

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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