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
  Purpose

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.


Condition Intervention Phase
Pain
Drug: AZD1386
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 6
Study Start Date: January 2009
Study Completion Date: February 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD1386
1 dose of oral solution

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832169

Locations
United Kingdom
Research Site
Macclesfield, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Raj Chetty, MD AstraZeneca R&D, CPU Alderley Park, UK
Study Chair: Lars Ståhle, MD AstraZeneca R&D, Södertälje, Sweden
  More Information

No publications provided

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia, Neuroscience, AstraZeneca R&D Södertälje, Sweden
ClinicalTrials.gov Identifier: NCT00832169     History of Changes
Other Study ID Numbers: D5090C00015, EudractCT: 2008-006552-22
Study First Received: January 29, 2009
Last Updated: April 27, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Pain

ClinicalTrials.gov processed this record on October 21, 2014