PharmacokineticsPhase 1NCT02126956
Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects
A Phase 1 study testing ACT-128800 in people with Pharmacokinetics, run by Actelion at 1 site in Switzerland.
Trial summary
The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of ACT-128800 in animals. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- ACT-128800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2009to Apr 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to any study-mandated procedure.
- Male and aged between 45 and 65 years (inclusive) at screening.
- No clinically significant findings on physical examination performed at screening.
- Body mass index (BMI) between 18-28 kg/m^2 (inclusive) at screening.
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart rate 55-90 bpm (inclusive), measured on the leading arm, after 5 minutes in the supine position at screening. These criteria should also be met before the administration of the first dose.
- 12-lead electrocardiogram without clinically relevant abnormalities at screening.
Show all 9Show fewer
- Clinical chemistry, hematology, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening.
- Negative results from urine drug screen at screening.
- Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.
Who cannot join
- Known hypersensitivity to any excipients of the drug formulation.
- Treatment with another investigational drug within the 3 months prior to screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Smoking within the 3 months prior to screening.
Show all 17Show fewer
- Any immunosuppressive treatment within 6 weeks before study drug administration.
- Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
- Loss of 250 mL or more of blood within the 3 months prior to screening.
- Lymphopenia (< 1,100 lymphocytes/μL).
- Viral, fungal, bacterial or protozoal infection within 4 weeks before study drug administration.
- Positive hepatitis B or hepatitis C serology, except for vaccinated subjects, at screening.
- Positive human immunodeficiency virus serology at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Legal incapacity or limited legal capacity at screening.
- Exposure to artificial ionizing radiation (e.g., X-ray, thyroid scan, study with radiolabeled compound) in the 12-month period before screening.
- A history of clinically relevant constipation (defined as lasting more than 3 days) in the 4-week period before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-label Study With 14C-labeled ACT-128800 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of ACT-128800 in animals.
- Conditions
- Pharmacokinetics
- Being tested
- ACT-128800
- Keywords
- ACT-128800
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-128800Drug
ACT-128800 was supplied as a powder mix in hard gelatin capsules for oral administration. The capsules contained a co-precipitated mixture of non-radiolabeled and 14C-labeled ACT-128800 formulated at a dose strength of 40 mg with a maximum radioactive content of 102 μCi (3.79 MBq).
| Study group | Role | What they receive |
|---|---|---|
| ACT-128800 | Experimental | Subjects received a single oral dose of 40 mg 14C-labeled ACT-128800 (one capsule) Receives: Drug: ACT-128800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative recovery of total radioactivity expressed as a percentage of the administered dose (mass balance) in the urine
On Day 1, immediately prior to the intake of study drug, subjects were instructed to empty their bladders. Thereafter, following drug intake all urine produced was collected for 10 days up to Day 11 (morning). Following administration of 14C-ACT-128800, urine samples were collected in three consecutive 8-hour intervals, from 0-8 h, 8-16 h, and 16-24 h. From Day 2 to Day 10 (inclusive), urine samples were collected at 24-hour intervals. In case of an extended observation period, urine samples were also collected at 24-hour intervals. The total amount of radioactivity was measured using a liquid scintillation counter.
Measured: Up to end of study, approximately 240 hours
Cumulative recovery of total radioactivity expressed as a percentage of the administered dose (mass balance) in the faeces
Between Day -3 and Day -1, a baseline faeces sample was collected in a light-protected polypropylene box from each subject.
From Day 1 (post-dose) to Day 10 (inclusive), all faeces samples and the toilet paper were collected in pre-weighed, light-protected polypropylene boxes. Each faeces sample was collected in a separate box and weighed. The weight of the sample and the time of collection were recorded. All faecal samples were frozen as soon as possible and stored in an upright position at -70 °C or below.The total amount of radioactivity was measured using a liquid scintillation counter.
Measured: Up to end of study, approximately 240 hours
Secondary outcomes (21)
Maximum concentration (Cmax) of 14C-radioactivity in whole blood
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. The measured radioactivity was used to directly obtain Cmax.
Measured: Up to end of study, approximately 240 hours
Time to maximum concentration (tmax) of 14C-radioactivity in whole blood
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. The measured radioactivity was used to directly obtain tmax.
Measured: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in whole blood
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. AUC(0-t) was calculated according to the linear trapezoidal rule, using the measured concentration-time values above the limit of quantification.
Measured: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in whole blood
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. AUC(0-infinity) was calculated by combining AUC(0-t) and AUC(extra). AUC(extra) represents an extrapolated value obtained by Ct/λz,, where Ct is the last concentration above the limit of quantification and λz, represents the terminal elimination rate constant determined by log-linear regression analysis of the measured concentrations in the terminal elimination phase.
Measured: Up to end of study, approximately 240 hours
Half life (t1/2) of 14C-radioactivity in whole blood
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. t1/2 was calculated as follows: t1/2 = ln 2/λz, where ln 2 is the natural log of 2 (approximately 0.693).
Measured: Up to end of study, approximately 240 hours
Maximum concentration (Cmax) of 14C-radioactivity in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. The measured radioactivity was used to directly obtain Cmax.
Measured: Up to end of study, approximately 240 hours
Time to maximum concentration (tmax) of 14C-radioactivity in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. The measured radioactivity was used to directly obtain tmax.
Measured: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. AUC(0-t) was calculated according to the linear trapezoidal rule, using the measured concentration-time values above the limit of quantification.
Measured: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity. The amount of radioactivity was measured using a liquid scintillation counter. AUC(0-infinity) was calculated by combining AUC(0-t) and AUC(extra). AUC(extra) represents an extrapolated value obtained by Ct/λz,, where Ct is the last concentration above the limit of quantification and λz, represents the terminal elimination rate constant determined by log-linear regression analysis of the measured concentrations in the terminal elimination phase.
Measured: Up to end of study, approximately 240 hours
Half life (t1/2) of 14C-radioactivity in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.0 mL was used for measurement of radioactivity.The amount of radioactivity was measured using a liquid scintillation counter. t1/2 was calculated as follows: t1/2 = ln 2/λz, where ln 2 is the natural log of 2 (approximately 0.693).
Measured: Up to end of study, approximately 240 hours
Maximum concentration (Cmax) of ACT-12880 in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.7 mL was used for measurement of ACT-12880 concentration. The concentration of ACT-128800 was determined using a validated liquid chromatography-tandem mass spectrometry assay was used to directly obtain Cmax.
Measured: Up to end of study, approximately 240 hours
Time to maximum concentration (tmax) of ACT-12880 in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.7 mL was used for measurement of ACT-12880 concentration. The concentration of ACT-128800 was determined using a validated liquid chromatography-tandem mass spectrometry assay was used to directly obtain tmax.
Measured: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-t)) of ACT-12880 in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.7 mL was used for measurement of ACT-12880 concentration. The concentration of ACT-128800 was determined using a validated liquid chromatography-tandem mass spectrometry assay . AUC(0-t) was calculated according to the linear trapezoidal rule, using the measured concentration-time values above the limit of quantification.
Measured: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of ACT-12880 in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.7 mL was used for measurement of ACT-12880 concentration. The concentration of ACT-128800 was determined using a validated liquid chromatography-tandem mass spectrometry assay . AUC(0-infinity) was calculated by combining AUC(0-t) and AUC(extra). AUC(extra) represents an extrapolated value obtained by Ct/λz,, where Ct is the last concentration above the limit of quantification and λz, represents the terminal elimination rate constant determined by log-linear regression analysis of the measured concentrations in the terminal elimination phase.
Measured: Up to end of study, approximately 240 hours
Half life (t1/2) of ACT-12880 in plasma
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.7 mL was used for measurement of ACT-12880 concentration. The concentration of ACT-128800 was determined using a validated liquid chromatography-tandem mass spectrometry assay . t1/2 was calculated as follows: t1/2 = ln 2/λz, where ln 2 is the natural log of 2 (approximately 0.693).
Measured: Up to end of study, approximately 240 hours
Total lymphocyte count
Blood samples were collected from an antecubital vein by direct venipuncture or via an intravenous catheter at various time points up to the end of study. An aliquot of 2.7 mL was used for measurement of lymphocyte count
Measured: Up to end of study, approximately 240 hours
Change in systolic blood pressure from baseline up to end of study
Blood pressure was measured at various time points up to the end of study using an automatic oscillometric device. Measurements were taken with the subject in the supine position after a resting period of at least 5 minutes. The leading (writing) arm was used for all blood pressure measurements.
Measured: Up to end of study, approximately 240 hours
Change in diastolic blood pressure from baseline up to end of study
Blood pressure was measured at various time points up to the end of study using an automatic oscillometric device. Measurements were taken with the subject in the supine position after a resting period of at least 5 minutes. The leading (writing) arm was used for all blood pressure measurements.
Measured: Up to end of study, approximately 240 hours
Change in heart rate from baseline up to end of study
Heart rate was measured at various time points up to the end of study using an automatic oscillometric device. Measurements were taken with the subject in the supine position after a resting period of at least 5 minutes. The leading (writing) arm was used for all blood pressure measurements.
Measured: Up to end of study, approximately 240 hours
Change in body temperature from baseline up to end of study
Body temperature was measured at various time points up to the end of study.
Measured: Up to end of study, approximately 240 hours
Change in body weight from baseline to end of study
Body weight was measured at baseline and at end of study using the same weighing scales for all subjects. The weighing scales had a precision of at least 0.5 kg.
Measured: Up to end of study, approximately 240 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMar 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Brossard, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126956
- Sponsor's protocol ID
- AC-058-106
- Status last verified
- Apr 2014
- First submitted
- 29 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label Study With 14C-labeled ACT-128800 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02126956
- Acronym / sponsor ID
- AC-058-106
- Conditions
- Pharmacokinetics
- Keywords
- ACT-128800
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Apr 2014 (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 study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of ACT-128800 in animals.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACT-128800 | Experimental | Drug: ACT-128800Subjects received a single oral dose of 40 mg 14C-labeled ACT-128800 (one capsule) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent prior to any study-mandated procedure.
- Male and aged between 45 and 65 years (inclusive) at screening.
- No clinically significant findings on physical examination performed at screening.
- Body mass index (BMI) between 18-28 kg/m^2 (inclusive) at screening.
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart rate 55-90 bpm (inclusive), measured on the leading arm, after 5 minutes in the supine position at screening. These criteria should also be met before the administration of the first dose.
Key exclusion criteria (17 listed)
- Known hypersensitivity to any excipients of the drug formulation.
- Treatment with another investigational drug within the 3 months prior to screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
- Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
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 |
|---|---|---|
| ACT-128800ACT-128800 was supplied as a powder mix in hard gelatin capsules for oral administration. The capsules contained a co-precipitated mixture of non-radiolabeled and 14C-labeled ACT-128800 formulated at a dose strength of 40 mg with a maximum radioactive content of 102 μCi (3.79 MBq). | Drug | ACT-128800 |
Primary outcome
Cumulative recovery of total radioactivity expressed as a percentage of the administered dose (mass balance) in the urine
Time frame: Up to end of study, approximately 240 hours
On Day 1, immediately prior to the intake of study drug, subjects were instructed to empty their bladders. Thereafter, following drug intake all urine produced was collected for 10 days up to Day 11 (morning). Following administration of 14C-ACT-128800, urine samples were collected in three consecutive 8-hour intervals, from 0-8 h, 8-16 h, and 16-24 h. From Day 2 to Day 10 (inclusive), urine samples were collected at 24-hour intervals. In case of an extended observation period, urine samples were also collected at 24-hour intervals. The total amount of radioactivity was measured using a liquid scintillation counter.
Cumulative recovery of total radioactivity expressed as a percentage of the administered dose (mass balance) in the faeces
Time frame: Up to end of study, approximately 240 hours
Between Day -3 and Day -1, a baseline faeces sample was collected in a light-protected polypropylene box from each subject. From Day 1 (post-dose) to Day 10 (inclusive), all faeces samples and the toilet paper were collected in pre-weighed, light-protected polypropylene boxes. Each faeces sample was collected in a separate box and weighed. The weight of the sample and the time of collection were recorded. All faecal samples were frozen as soon as possible and stored in an upright position at -70 °C or below.The total amount of radioactivity was measured using a liquid scintillation counter.
21 secondary outcomes
Maximum concentration (Cmax) of 14C-radioactivity in whole blood
Time frame: Up to end of study, approximately 240 hours
Time to maximum concentration (tmax) of 14C-radioactivity in whole blood
Time frame: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in whole blood
Time frame: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in whole blood
Time frame: Up to end of study, approximately 240 hours
Half life (t1/2) of 14C-radioactivity in whole blood
Time frame: Up to end of study, approximately 240 hours
Maximum concentration (Cmax) of 14C-radioactivity in plasma
Time frame: Up to end of study, approximately 240 hours
Time to maximum concentration (tmax) of 14C-radioactivity in plasma
Time frame: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-t)) of 14C-radioactivity in plasma
Time frame: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of 14C-radioactivity in plasma
Time frame: Up to end of study, approximately 240 hours
Half life (t1/2) of 14C-radioactivity in plasma
Time frame: Up to end of study, approximately 240 hours
Maximum concentration (Cmax) of ACT-12880 in plasma
Time frame: Up to end of study, approximately 240 hours
Time to maximum concentration (tmax) of ACT-12880 in plasma
Time frame: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-t)) of ACT-12880 in plasma
Time frame: Up to end of study, approximately 240 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of ACT-12880 in plasma
Time frame: Up to end of study, approximately 240 hours
Half life (t1/2) of ACT-12880 in plasma
Time frame: Up to end of study, approximately 240 hours
Total lymphocyte count
Time frame: Up to end of study, approximately 240 hours
Change in systolic blood pressure from baseline up to end of study
Time frame: Up to end of study, approximately 240 hours
Change in diastolic blood pressure from baseline up to end of study
Time frame: Up to end of study, approximately 240 hours
Change in heart rate from baseline up to end of study
Time frame: Up to end of study, approximately 240 hours
Change in body temperature from baseline up to end of study
Time frame: Up to end of study, approximately 240 hours
Change in body weight from baseline to end of study
Time frame: Up to end of study, approximately 240 hours
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 30 Apr 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.
Patrick Brossard, PhD study director
Actelion
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 ACT-128800 in people with Pharmacokinetics, run by Actelion at 1 site in Switzerland.
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 17 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 30 Apr 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 Switzerland. 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?
Cumulative recovery of total radioactivity expressed as a percentage of the administered dose (mass balance) in the urine (time frame: Up to end of study, approximately 240 hours). 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 30 Apr 2014.