Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers (ADME)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01058447
First received: January 26, 2010
Last updated: November 17, 2010
Last verified: November 2010
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Purpose
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: AZD1981 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Bio-availability Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Pharmacokinetic variables and Radioactivity [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) [ Time Frame: Frequent sampling occasions during study days ] [ Designated as safety issue: Yes ]
| Enrollment: | 4 |
| Study Start Date: | February 2010 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: AZD1981
Oral tablet, 250 mg, single dose
|
Eligibility| Ages Eligible for Study: | 50 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study specific procedure
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
Exclusion Criteria:
- Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
- History or presence of any clinically significant disease or disorder in the opinion of the investigator
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058447
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Eva S Pettersson | AstraZeneca R&D, Lund, Sweden |
| Principal Investigator: | Tim Mant, Professor | Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom |
More Information
No publications provided
| Responsible Party: | MSD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01058447 History of Changes |
| Other Study ID Numbers: | D9830C00006 |
| Study First Received: | January 26, 2010 |
| Last Updated: | November 17, 2010 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
ADME Healthy volunteers |
ClinicalTrials.gov processed this record on May 21, 2013