NCT01048203

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

August 27, 2014

Status Verified

August 1, 2014

Enrollment Period

2 months

First QC Date

January 8, 2010

Last Update Submit

August 26, 2014

Conditions

Healthy

Keywords

14C ABR 215050 Metabolism and Mass Balance StudytasquinimodMetabolic pattern of 14C ABR-215050

Outcome Measures

Primary Outcomes (1)

  • To establish the metabolic pattern of ABR 215050

    4 months

Secondary Outcomes (2)

  • To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050.

    4 months

  • To follow the safety profile

    4 months

Study Arms (1)

ABR-215050

EXPERIMENTAL
Drug: ABR-215050

Interventions

ABR-215050DRUG

1 mg ABR-215050

Also known as: tasquinimod
ABR-215050

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JJ Berzelius Clinical Research Center AB, Berzelius Science Park

Linköping, 582 25, Sweden

Location

MeSH Terms

Interventions

tasquinimod

Study Officials

  • Marianne Ellman, BSc

    Active Biotech Research AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 13, 2010

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 27, 2014

Record last verified: 2014-08

Locations

SE(1)