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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00832169
First received: January 29, 2009
Last updated: April 27, 2009
Last verified: April 2009

January 29, 2009
April 27, 2009
January 2009
Not Provided
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00832169 on ClinicalTrials.gov Archive Site
  • AZD1386 metabolites in plasma+excreta if feasable [ Time Frame: Predose, 1h, 4h, 8h 24h ] [ Designated as safety issue: No ]
  • Safety + tolerability of AZD1386 [ Time Frame: Predose, 2h, 6h, 12h, 24h, 48h, 168h ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Investigation of Rate+Extent of Excretion of Radioactivity in Urine+Faeces After Oral Administration of [14C]AZD1386
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pain
Drug: AZD1386
1 dose of oral solution
Experimental: 1
Intervention: Drug: AZD1386
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
February 2009
Not Provided

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.
Male
35 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00832169
D5090C00015, EudractCT: 2008-006552-22
No
Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience, AstraZeneca R&D Södertälje, Sweden
AstraZeneca
Not Provided
Principal Investigator: Raj Chetty, MD AstraZeneca R&D, CPU Alderley Park, UK
Study Chair: Lars Ståhle, MD AstraZeneca R&D, Södertälje, Sweden
AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP