HealthyPhase 1NCT02142127

Mass Balance Study of 14C-labelled GFT505 in Healthy Volunteers

A Phase 1 study testing 14C-labelled GFT505 120 mg in people with Healthy, run by Genfit at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Human mass-balance studies with radiolabelled study drug are needed to evaluate the amount of drug that is recovered over time via different elimination routes of the body, i.e., whole blood, blood cells, plasma, urine, feces, and expired air. Read more about this study

Who is it for?: Ages 55 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 14C-labelled GFT505 120 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteBelgium
Study dates: Apr 2014to Apr 2015
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 55 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy Caucasian males aged 55 to 65 years inclusive
Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m²
Fitzpatrick skin type < 4
No clinically relevant abnormalities in hematology and clinical chemistry parameters, blood pressure (BP) and heart rate (HR) (supine), or ECG results

Who cannot join

History or presence of any hepatic, renal, respiratory, cardiovascular, neurologic, gastrointestinal, endocrine, immunologic, musculoskeletal, or hematologic disorder capable of altering the absorption, metabolism, or elimination of drugs, or capable of constituting a risk factor when taking the study drug, as judged by the investigator;
Creatinine Clearance as calculated by the Cockcroft-Gault formula less than 60 mL/min;
History of irregular bowel movements such as regular episodes of diarrhea, constipation (less than a mean of one bowel movement per day) or irritable bowel movement;
Planning to become a father or to donate sperm within 3 months after the administration of study drug;
History or presence of drug addiction (positive drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or excessive use of alcohol (daily intake exceeding 2 units/day);
Current use of nicotine containing products, i.e., more than 5 cigarettes or equivalent/day and the inability to stop using nicotine containing products during confinement in the clinical center;

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Large caffeine consumption (daily average of more than 6 cups of coffee or tea or more than 1L of caffeine-containing beverages) within the last year;
Plasma levels of ALT, AST, or alkaline phosphatase (ALP) ≥1.5 x upper limit of laboratory normal range (ULN);
Blood donation or loss of significant amount of blood within 12 weeks prior to dosing;
Inability to understand the constraints of full urine and stool collection or inability to collect urine;
Use of any drug treatment that could affect the outcome of the study from 14 days before the administration of the radiolabelled study drug (2 months for enzyme-inducing drugs) or 5 times the half-life of the medication, or anticipated use of concomitant therapy (except paracetamol) during the study;
Exposure to ionizing radiations (except routine or dental radiography or radiography of the extremities), including participation in studies with radiolabelled compounds, or exposure to radioisotopes within one year prior to entry into the present study;
Participation in another clinical study within 12 weeks prior to entry into the present study.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Life Science Services
Antwerp, 2060

Other trials in Belgium

About this study

Official title: An Open-Label, Single Oral Dose Phase I Study to Determine the Excretion Balance of Radiocarbon (i.e., the Sum of 14C-Labelled GFT505 and Its 14C-Metabolites) and to Investigate the Metabolic Profile and Pharmacokinetics of GFT505

A good understanding of the metabolic pathway of the study drug is equally important. Mass-balance data, together with metabolic profiles in excreta, are used to characterize the biotransformation pathways of a drug and to help evaluate its drug-drug interaction potential.

To this purpose, in this study, blood, urine, and feces are collected to investigate the metabolic profile of GFT505, and plasma and urine are collected to investigate the non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007. Other metabolites will be investigated in plasma and urine according to the radioactivity results. Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated according to the radioactivity results.

Read the detailed description

This is a Phase I open-label, single oral dose and single center study of 14C-labelled GFT505 and its metabolites in healthy subjects.

After an overnight fast, subjects will be administered one dose of 14C-labelled GFT505 containing an equivalent of 120 mg of the compound with 240 mL of non-carbonated water. The total amount of administered radiocarbon will be 1.63-1.81 megaBecquerel (MBq) (44.1-48.8 μCi).

Blood, urine, and feces will be collected at scheduled time intervals from before administration of the radiolabelled study drug throughout confinement at the clinical center and thereafter, if needed. Several samples of expired carbon dioxide will be obtained up to 48 h after the administration of radiolabelled study drug.

Radiocarbon will be assayed in all available samples (whole blood, plasma, urine, feces, and expired air) by liquid scintillation spectrometry. The metabolic profile of GFT505 will be assayed in plasma, urine, and feces. Non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007 will be assayed in plasma and urine. Other metabolites will be investigated in plasma and urine according to the radioactivity results. Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated according to the radioactivity results.

Conditions: Healthy
Being tested: 14C-labelled GFT505 120 mg
Keywords: GFT505, Mass balance, Pharmacokinetics, Metabolites, Healthy subjects, Healthy male volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

14C-labelled GFT505 120 mgDrug

Study groups in NCT02142127
Study group	Role	What they receive
14C-labelled GFT505 120 mg	Experimental	Not described Receives: Drug: 14C-labelled GFT505 120 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Excretion balance of radiocarbon in whole blood, blood cells, plasma, urine, feces, and expired air after a single oral dose of 14C-labelled GFT505.
Blood, urine, and feces will be collected at scheduled time intervals from before administration of the radiolabelled study drug throughout confinement at the clinical center and thereafter, if needed. Several samples of expired carbon dioxide will be obtained up to 48 h after the administration of radiolabelled study drug.
Radiocarbon will be assayed in all available samples (whole blood, plasma, urine, feces, and expired air) by liquid scintillation spectrometry.
Measured: 0-19 days

Secondary outcomes (2)

Metabolic profile of GFT505 in plasma, urine, and feces.
The metabolic profile of GFT505 will be assayed in plasma, urine, and feces. Non-radioactive pharmacokinetics of GFT505 and its principle metabolite GFT1007 will be assayed in plasma and urine. Other metabolites will be investigated in plasma and urine according to the radioactivity results. Non-radioactive pharmacokinetics of GFT505 and metabolites in feces will be investigated according to the radioactivity results.
Measured: 0- 19 days
Safety parameters
Safety assessment will be based on adverse events (AEs), clinical laboratory tests, electrocardiogram (ECG), vital signs, and physical examination.
Measured: 0 - 19 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Apr 2015

First posted20 May 2014 (estimated)
Study startApr 2014
Primary completionJun 2014
Study completionApr 2015

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02142127
Sponsor's protocol ID: GFT505-114-10
Other IDs: 2014-000958-10, 2014
Status last verified: May 2015
First submitted: 16 May 2014
Last updated: 29 May 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single Oral Dose Phase I Study to Determine the Excretion Balance of Radiocarbon (i.e., the Sum of 14C-Labelled GFT505 and Its 14C-Metabolites) and to Investigate the Metabolic Profile and Pharmacokinetics of GFT505
ClinicalTrials.gov ID: NCT02142127
Acronym / sponsor ID: GFT505-114-10
Conditions: Healthy
Keywords: GFT505, Mass balance, Pharmacokinetics, Metabolites, Healthy subjects, Healthy male volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: GenfitIndustry (pharma, biotech, devices)
Collaborators: SGS Life Sciences, a division of SGS Belgium NV
Study start: Apr 2014
Primary completion: Jun 2014 (actual)
Study completion: Apr 2015 (actual)
First posted: 20 May 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.

Detailed description

This is a Phase I open-label, single oral dose and single center study of 14C-labelled GFT505 and its metabolites in healthy subjects.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
14C-labelled GFT505 120 mg	Experimental	Drug: 14C-labelled GFT505 120 mg

Who may qualify

Ages: 55 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy Caucasian males aged 55 to 65 years inclusive
Body Mass Index (BMI) ≥ 18 ≤ 30 kg/m²
Fitzpatrick skin type < 4
No clinically relevant abnormalities in hematology and clinical chemistry parameters, blood pressure (BP) and heart rate (HR) (supine), or ECG results

Key exclusion criteria (13 listed)

History or presence of any hepatic, renal, respiratory, cardiovascular, neurologic, gastrointestinal, endocrine, immunologic, musculoskeletal, or hematologic disorder capable of altering the absorption, metabolism, or elimination of drugs, or capable of constituting a risk factor when taking the study drug, as judged by the investigator;
Creatinine Clearance as calculated by the Cockcroft-Gault formula less than 60 mL/min;
History of irregular bowel movements such as regular episodes of diarrhea, constipation (less than a mean of one bowel movement per day) or irritable bowel movement;
Planning to become a father or to donate sperm within 3 months after the administration of study drug;
History or presence of drug addiction (positive drug screen for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, or opiates) or excessive use of alcohol (daily intake exceeding 2 units/day);

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
14C-labelled GFT505 120 mg	Drug	14C-labelled GFT505 120 mg

Primary outcome

Excretion balance of radiocarbon in whole blood, blood cells, plasma, urine, feces, and expired air after a single oral dose of 14C-labelled GFT505.
Time frame: 0-19 days
Blood, urine, and feces will be collected at scheduled time intervals from before administration of the radiolabelled study drug throughout confinement at the clinical center and thereafter, if needed. Several samples of expired carbon dioxide will be obtained up to 48 h after the administration of radiolabelled study drug. Radiocarbon will be assayed in all available samples (whole blood, plasma, urine, feces, and expired air) by liquid scintillation spectrometry.

2 secondary outcomes

Metabolic profile of GFT505 in plasma, urine, and feces.
Time frame: 0- 19 days
Safety parameters
Time frame: 0 - 19 days

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 29 May 2015.

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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.

Sophie Megnien, MD study director

Chief Medical Officer, Genfit

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 14C-labelled GFT505 120 mg in people with Healthy, run by Genfit at 1 site in Belgium.

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 4 inclusion and 13 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 29 May 2015. 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 Belgium. 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?

Excretion balance of radiocarbon in whole blood, blood cells, plasma, urine, feces, and expired air after a single oral dose of 14C-labelled GFT505. (time frame: 0-19 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02142127.

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 29 May 2015.