HealthyPhase 1NCT00868361
A Study to Investigate the Absorption, Metabolism and Excretion of Talampanel
A Phase 1 study testing Talampanel (non-radiolabeled), [14C] Talampanel in people with Healthy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to characterize the chemical breakdown and excretion of talampanel and its break down products in plasma, feces, and urine of healthy human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Talampanel (non-radiolabeled), [14C] Talampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Sep 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males, between 18 and 55 years of age, inclusive
- Body Mass Index range 18.0 to 30.0 kg/m2, inclusive
- Have NAT2 slow or rapid acetylator genotype
- In good health as determined by the investigator
- Negative test for selected drugs of abuse at screening
- Negative screens for Hepatitis B, Hepatitis C and HIV
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- Sterile or agrees to use an approved method of contraception from Check-in until 45 days following Clinic Discharge
- Able to comprehend and willing to sign an Informed Consent Form
- Have 1 to 2 bowel movements per day
Who cannot join
- Significant history or clinical manifestation of any significant metabolic, allergic, skin, liver, kidney, blood, heart or blood vessel, digestive system, brain or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection
- History or presence of an abnormal ECG,
- History of clinically significant alcohol or drug use within 1 year prior to Check-in
- Participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in
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- Exposure to significant radiation within 12 months prior to Check-in -Use of any tobacco- or nicotine-containing within 6 months prior to Check- in
- Use of any drugs which may interact with the study drug within 30 days prior to Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in
- Use of any prescription medications/products within 14 days prior to Check in
- Use of any over-the-counter, non-prescription drugs within 7 days prior to Check-in
- Use of grapefruit or grapefruit-containing foods or beverages within 7 days prior to Check-in
- Use of alcohol- or caffeine-containing foods or beverages within 72 hours prior to Check-in
- Donation of blood from 30 days prior to Screening through Study Completion, inclusive, or of plasma from 2 weeks prior to Screening through Study Completion
- Receipt of blood products within 2 months prior to Check-in
- Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Pharmacology Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1 Open-label Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Talampanel Following Oral Administration to Healthy Male
The purpose of this study is to characterize the chemical breakdown and excretion of talampanel and its break down products in plasma, feces, and urine of healthy human volunteers.
- Conditions
- Healthy
- Being tested
- Talampanel (non-radiolabeled), [14C] Talampanel
- Keywords
- Mass Balance, Talampanel, Pharmacokinetics, Metabolism, Metabolites, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talampanel (non-radiolabeled), [14C] TalampanelDrug
Also called TV-7600
50 mg capsule single dose
| Study group | Role | What they receive |
|---|---|---|
| Slow and rapid N-acetyl transferase genotypes | Experimental | Not described Receives: Drug: Talampanel (non-radiolabeled), [14C] Talampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the mass balance of [14C]-talampanel. To characterize the metabolism of [14C] talampanel in plasma, feces, and urine. To assess the pharmacokinetics (PK) of total radioactivity, talampanel, and N-acetyl talampanel.
Measured: 6-9 days
Secondary outcomes (1)
To explore the effect of N-acetyltransferase 2 (NAT2) genotype on the PK and metabolism of [14C] talampanel. To further assess the safety and tolerability of talampanel.
Measured: 6-9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Poor recruitment of fast and slow acetylators
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Investigators
- Nicholas M Siebers, MD, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00868361
- Sponsor's protocol ID
- TAL-MB-100
- Status last verified
- Sep 2009
- First submitted
- 24 Mar 2009
- Last updated
- 16 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-label Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Talampanel Following Oral Administration to Healthy Male
- ClinicalTrials.gov ID
- NCT00868361
- Acronym / sponsor ID
- TAL-MB-100
- Conditions
- Healthy
- Keywords
- Mass Balance, Talampanel, Pharmacokinetics, Metabolism, Metabolites, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment of fast and slow acetylators
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Mar 2009 (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.
The purpose of this study is to characterize the chemical breakdown and excretion of talampanel and its break down products in plasma, feces, and urine of healthy human volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slow and rapid N-acetyl transferase genotypes | Experimental | Drug: Talampanel (non-radiolabeled), [14C] Talampanel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Males, between 18 and 55 years of age, inclusive
- Body Mass Index range 18.0 to 30.0 kg/m2, inclusive
- Have NAT2 slow or rapid acetylator genotype
- In good health as determined by the investigator
- Negative test for selected drugs of abuse at screening
Key exclusion criteria (16 listed)
- Significant history or clinical manifestation of any significant metabolic, allergic, skin, liver, kidney, blood, heart or blood vessel, digestive system, brain or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection
- History or presence of an abnormal ECG,
- History of clinically significant alcohol or drug use within 1 year prior to Check-in
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 |
|---|---|---|
| Talampanel (non-radiolabeled), [14C] TalampanelAlso: TV-760050 mg capsule single dose | Drug | Slow and rapid N-acetyl transferase genotypes |
Primary outcome
To determine the mass balance of [14C]-talampanel. To characterize the metabolism of [14C] talampanel in plasma, feces, and urine. To assess the pharmacokinetics (PK) of total radioactivity, talampanel, and N-acetyl talampanel.
Time frame: 6-9 days
1 secondary outcome
To explore the effect of N-acetyltransferase 2 (NAT2) genotype on the PK and metabolism of [14C] talampanel. To further assess the safety and tolerability of talampanel.
Time frame: 6-9 days
Results and safety
The study was stopped early (reason given: Poor recruitment of fast and slow acetylators). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2009.
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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.
Nicholas M Siebers, MD principal investigator
Covance
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 Talampanel (non-radiolabeled), [14C] Talampanel in people with Healthy, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
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 9 inclusion and 16 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: stopped early, as of the sponsor's last update on 16 Sep 2009. 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 United States. 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 was stopped early (reason given: Poor recruitment of fast and slow acetylators). Results are not available in the source record.
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 determine the mass balance of [14C]-talampanel. To characterize the metabolism of [14C] talampanel in plasma, feces, and urine. To assess the pharmacokinetics (PK) of total radioactivity, talampanel, and N-acetyl talampanel. (time frame: 6-9 days). 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 16 Sep 2009.