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

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00832169
• Other study ID #: D5090C00015
• Secondary ID: EudractCT: 2008-
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: April 27, 2009
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• AZD1386
1 dose of oral solution

Locations

Country	Name	City	State
United Kingdom	Research Site	Macclesfield	Cheshire

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excretion (rate+extent) of radioactivity in urine+faeces following oral administration of [14C]AZD1386		Until >90% of predicted total radioactivity has been recovered	No
Primary	Pharmacokinetics of total radioactivity in plasma + unchanged AZD1386 in plasma Metabolite profile in plasma+excreta		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	No
Secondary	AZD1386 metabolites in plasma+excreta if feasable		Predose, 1h, 4h, 8h 24h	No
Secondary	Safety + tolerability of AZD1386		Predose, 2h, 6h, 12h, 24h, 48h, 168h	Yes