HealthyPhase 1NCT01048203
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
A Phase 1 study testing ABR-215050 in people with Healthy, run by Active Biotech AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ABR-215050
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
JJ Berzelius Clinical Research Center AB, Berzelius Science Park
Linköping, 582 25
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- ABR-215050
- Keywords
- 14C ABR 215050 Metabolism and Mass Balance Study, tasquinimod, Metabolic pattern of 14C ABR-215050
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABR-215050Drug
Also called tasquinimod
1 mg ABR-215050
| Study group | Role | What they receive |
|---|---|---|
| ABR-215050 | Experimental | Not described Receives: Drug: ABR-215050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the metabolic pattern of ABR 215050
Measured: 4 months
Secondary outcomes (2)
To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050.
Measured: 4 months
To follow the safety profile
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Active Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Ellman, BSc, Study director, Active Biotech Research AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048203
- Sponsor's protocol ID
- 08TASQ09
- Other IDs
- 2008-003163-39, 2008
- Status last verified
- Aug 2014
- First submitted
- 8 Jan 2010
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01048203
- Acronym / sponsor ID
- 08TASQ09
- Conditions
- Healthy
- Keywords
- 14C ABR 215050 Metabolism and Mass Balance Study, tasquinimod, Metabolic pattern of 14C ABR-215050
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Active Biotech ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABR-215050 | Experimental | Drug: ABR-215050 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABR-215050Also: tasquinimod1 mg ABR-215050 | Drug | ABR-215050 |
Primary outcome
To establish the metabolic pattern of ABR 215050
Time frame: 4 months
2 secondary outcomes
To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050.
Time frame: 4 months
To follow the safety profile
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Ellman, BSc study director
Active Biotech Research AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABR-215050 in people with Healthy, run by Active Biotech AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the metabolic pattern of ABR 215050 (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.