HealthyPhase 1NCT01380561
A Metabolite Identification, Mass Balance, and PK Study of [14C]-Asimadoline to Healthy Adult Male Volunteers
A Phase 1 study testing asimadoline in people with Healthy, run by Tioga Pharmaceuticals at 1 site in United States.
Trial summary
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 56 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- asimadoline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2011
- 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 56 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be informed of the nature of the study and have provided written informed voluntary consent
- Be healthy males, at least 18 years of age or the legal age of consent (whichever is greater) and less than 56 years of age
- Have a body mass index (BMI) >=18.0 and <32.0 kg/m2 and weigh at least 50 kg
- Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry, urinalysis), and 12 lead electrocardiogram (ECG) that, in the opinion of the Investigator, would affect subject safety
- Agree to comply with the study procedures and restrictions.
Who cannot join
- Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease
- Receipt of a radioisotope with an effective half-life of 30 days or more within the previous 12 months
- Receipt of any diagnostic radiation procedures with an effective dose exceeding 1 rem in their lifetime
- Occupational exposure to radiation (e.g., those routinely required to wear a radiation monitoring badge)
- Receipt of any radiation treatments/therapy
- History of constipation or infrequent bowel movements (<=6 bowel movements per week on average)
Show all 15Show fewer
- Known or suspected hypersensitivity or allergic reaction to asimadoline or similar chemical compounds or any of the components of asimadoline tablets
- Chronic use of any systemic medications (with the exception of vitamins taken at standard supplement doses); use of a drug therapy (including herbal preparations, e.g., St. John's wort) known to induce or inhibit hepatic drug metabolism within 30 days before the first dose of study medication; use of prescription medication within 14 days before administration of study medication or over-the-counter products (including natural products) within 7 days before administration of study medication, except for topical products without systemic absorption, unless approved by the Sponsor
- Have smoked cigarettes or used nicotine-containing products over the last 3 months and not able to abstain from smoking for the duration of the confinement period
- If not sterile, cannot agree to use one of the following approved methods of contraception, from check-in until 3 months following Study Completion/Clinic Discharge: a male condom with spermicide; a sterile sexual partner; use by a female sexual partner of an intrauterine device with spermicide; a female condom with spermicide; contraceptive sponge with spermicide; a cervical cap with spermicide; or oral, implantable, transdermal, or injectable contraceptives with a reliable secondary back-up method
- Current history or evidence of drug or alcohol abuse or a positive screen for substances of abuse or alcohol at screening or admission
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
- Receipt of an investigational product or device, or participation in a drug research study within a period of 30 days (or 5 half lives of the drug, whichever is longer) before the first dose of study medication
- Blood loss or blood donation of >550 mL within 90 days or plasma donation >500 mL within 30 days before administration of study drug
- Any food allergy, intolerance, restriction, or special diet that, in the opinion of the Investigator, should preclude the subject's participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Metabolite Identification, Mass Balance, and Pharmacokinetic Study of a Single Oral Dose of [14C]-Asimadoline Followed by Twice Daily Oral Dosing of 0.5 mg Asimadoline to Healthy Adult Male Volunteers
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.
Read the detailed description
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers. The purposes of this study is to determine the excretion of total [14C] derived radioactivity and the metabolite profile after a single oral dose of [14C] asimadoline as well as to identify and quantitate the metabolites of asimadoline in plasma, urine, and feces after single and multiple oral doses of asimadoline.
- Conditions
- Healthy
- Being tested
- asimadoline
- Keywords
- asimadoline, pharmacokinetic, excretion of 14C-derived radioactivity, metabolite profile, 14C-asimadoline, metabolites, single and multiple oral doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asimadolineDrug
Also called EMD 61 753, EMR 63 320
10mg [14]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | asimadoline Receives: Drug: asimadoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of [14C]derived radioactivity in urine and feces after a single oral dose of [14C]asimadoline
Measured: up to 1 month
Concentration of metabolites of asimadoline in plasma, urine, and feces after single and multiple oral doses of asimadoline.
Measured: up to 1 month
Secondary outcomes (2)
Determination of plasma pharmacokinetics (e.g., Cmax, AUC, tmax, t1/2) of asimadoline and major metabolites
Measured: up to 1 month
Number of subjects with adverse events
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionJul 2011
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tioga Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Philip Leese, Principal investigator, Quintiles Phase 1 Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380561
- Sponsor's protocol ID
- ASMP1001
- Status last verified
- Oct 2011
- First submitted
- 13 Jun 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Metabolite Identification, Mass Balance, and Pharmacokinetic Study of a Single Oral Dose of [14C]-Asimadoline Followed by Twice Daily Oral Dosing of 0.5 mg Asimadoline to Healthy Adult Male Volunteers
- ClinicalTrials.gov ID
- NCT01380561
- Acronym / sponsor ID
- ASMP1001
- Conditions
- Healthy
- Keywords
- asimadoline, pharmacokinetic, excretion of 14C-derived radioactivity, metabolite profile, 14C-asimadoline, metabolites, single and multiple oral doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tioga PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Jun 2011 (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 an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers.
Detailed description
This is an open label, single center, metabolite identification, mass balance, and PK study in healthy male volunteers. The purposes of this study is to determine the excretion of total [14C] derived radioactivity and the metabolite profile after a single oral dose of [14C] asimadoline as well as to identify and quantitate the metabolites of asimadoline in plasma, urine, and feces after single and multiple oral doses of asimadoline.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Drug: asimadolineasimadoline |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be informed of the nature of the study and have provided written informed voluntary consent
- Be healthy males, at least 18 years of age or the legal age of consent (whichever is greater) and less than 56 years of age
- Have a body mass index (BMI) >=18.0 and <32.0 kg/m2 and weigh at least 50 kg
- Be in good general health with no clinically relevant abnormalities based on the medical history, physical examination, clinical laboratory evaluations (hematology, clinical chemistry, urinalysis), and 12 lead electrocardiogram (ECG) that, in the opinion of the Investigator, would affect subject safety
- Agree to comply with the study procedures and restrictions.
Key exclusion criteria (15 listed)
- Any disease or condition that might affect drug absorption, metabolism, or excretion, or clinically significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, dermatological, neurological, or psychiatric disease
- Receipt of a radioisotope with an effective half-life of 30 days or more within the previous 12 months
- Receipt of any diagnostic radiation procedures with an effective dose exceeding 1 rem in their lifetime
- Occupational exposure to radiation (e.g., those routinely required to wear a radiation monitoring badge)
- Receipt of any radiation treatments/therapy
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 |
|---|---|---|
| asimadolineAlso: EMD 61 753, EMR 63 32010mg [14]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5. | Drug | Single Arm Study |
Primary outcome
Amount of [14C]derived radioactivity in urine and feces after a single oral dose of [14C]asimadoline
Time frame: up to 1 month
Concentration of metabolites of asimadoline in plasma, urine, and feces after single and multiple oral doses of asimadoline.
Time frame: up to 1 month
2 secondary outcomes
Determination of plasma pharmacokinetics (e.g., Cmax, AUC, tmax, t1/2) of asimadoline and major metabolites
Time frame: up to 1 month
Number of subjects with adverse events
Time frame: up to 1 month
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 18 Oct 2011.
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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.
Dr. Philip Leese principal investigator
Quintiles Phase 1 Unit
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 asimadoline in people with Healthy, run by Tioga Pharmaceuticals 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 5 inclusion and 15 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 18 Oct 2011. 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 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?
Amount of [14C]derived radioactivity in urine and feces after a single oral dose of [14C]asimadoline (time frame: up to 1 month). The study lists 2 primary outcomes in all. 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 18 Oct 2011.