A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects

Healthy Clinical Trial

Official title:

An Open Label, Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048203
• Other study ID #: 08TASQ09
• Secondary ID: 2008-003163-39
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2010
• Last updated: August 26, 2014
• Start date: January 2009
• Est. completion date: March 2009

Study information

• Verified date: August 2014
• Source: Active Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 40-65 year old male and female subjects.

2. Healthy according to medical history, physical examination and clinical chemistry, urine and hematological laboratory tests.

3. Body Mass Index (BMI) of 18-30.

4. Negative screen for Hepatitis B / C and HIV-infection.

5. Be willing and able to comply with the protocol for the duration of the study.

6. 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.

7. Have given written signed informed consent, prior to start of any study-related activities.

Exclusion Criteria:

1. Gastrointestinal disorders that may affect drug absorption.

2. Any vaccination within 30 days before start of this study and throughout the study.

3. Blood donation within 90 days before start of this study and for 90 days after the study.

4. 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.

5. Perform any planned surgery

6. Any use of nicotine within three (3) months before start of this study and throughout the study.

7. Known or suspected history of alcoholism or drug abuse.

8. Intake of alcoholic beverages for 24 hours prior to the administration of investigational product and for 24 hours after the dose.

9. Intake of caffeine containing beverages 10 hours prior to the administration of investigational product and for 6 hours after the dose.

10. Medication including herbal remedies (vitamins and paracetamol excluded) within 14 days before and throughout the study.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ABR-215050
1 mg ABR-215050

Locations

Country	Name	City	State
Sweden	JJ Berzelius Clinical Research Center AB, Berzelius Science Park	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Active Biotech AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the metabolic pattern of ABR 215050		4 months	Yes
Secondary	To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050.		4 months	Yes
Secondary	To follow the safety profile		4 months	Yes