- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01048203
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
August 26, 2014 updated by: Active Biotech AB
An Open Label, Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
This is a single site, open label, single dose, non-randomized study in healthy male and female subjects.
The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.
Study Overview
Detailed Description
As a part of the pharmacokinetic documentation, the metabolism and mass balance of 14C-ABR-215050 will be studied in healthy subjects.
Female healthy subjects are included in the study in case of expanding the indication to female forms of cancer.
In this study a single dose of 1.0 mg of the study drug will be administered orally as a solution under fasted conditions.
The absorption and safety profiles for the oral water solution will also be documented.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linköping, Sweden, 582 25
- JJ Berzelius Clinical Research Center AB, Berzelius Science Park
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 40-65 year old male and female subjects.
- Healthy according to medical history, physical examination and clinical chemistry, urine and hematological laboratory tests.
- Body Mass Index (BMI) of 18-30.
- Negative screen for Hepatitis B / C and HIV-infection.
- Be willing and able to comply with the protocol for the duration of the study.
- Women of childbearing potential must be neither pregnant nor breast-feeding. Confirmation that the subject is not pregnant must be established by a pregnancy test before the single dose and at study end. Fertile women must be willing to practice reliable methods of contraception. Medically accepted safe methods of contraception for the purpose of this study will include surgical sterilisation, intra-uterine device, diaphragm with spermicide, or condom with spermicide. As interaction studies between ABR-215050 and hormonal (oral or depot) contraceptives have not yet been performed, women using such devices must also use a complementary contraceptive device.
- Have given written signed informed consent, prior to start of any study-related activities.
Exclusion Criteria:
- Gastrointestinal disorders that may affect drug absorption.
- Any vaccination within 30 days before start of this study and throughout the study.
- Blood donation within 90 days before start of this study and for 90 days after the study.
- Participation in other clinical studies or who have received other investigational drugs within 90 days prior to enrolment. Additionally, subjects previously included into this study and then are withdrawn from the study is not to be re-entered into the study.
- Perform any planned surgery
- Any use of nicotine within three (3) months before start of this study and throughout the study.
- Known or suspected history of alcoholism or drug abuse.
- Intake of alcoholic beverages for 24 hours prior to the administration of investigational product and for 24 hours after the dose.
- Intake of caffeine containing beverages 10 hours prior to the administration of investigational product and for 6 hours after the dose.
- Medication including herbal remedies (vitamins and paracetamol excluded) within 14 days before and throughout the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ABR-215050
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1 mg ABR-215050
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish the metabolic pattern of ABR 215050
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050.
Time Frame: 4 months
|
4 months
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To follow the safety profile
Time Frame: 4 months
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4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Marianne Ellman, BSc, Active Biotech Research AB
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
January 8, 2010
First Submitted That Met QC Criteria
January 12, 2010
First Posted (Estimate)
January 13, 2010
Study Record Updates
Last Update Posted (Estimate)
August 27, 2014
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 08TASQ09
- 2008-003163-39 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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