HealthyPhase 1NCT02068235
Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects
A Phase 1 study testing Ponesimod 5mg i.v., Ponesimod i.v. and Ponesimod 10 mg tablet in people with Healthy, run by Actelion at 1 site in United Kingdom.
Trial summary
This study consists of a single-dose pilot phase and a randomized, two-way crossover, single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod formulation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ponesimod 5mg i.v., Ponesimod i.v. and Ponesimod 10 mg tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Nov 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent in the local language prior to any study-mandated procedure.
- Body mass index ≥ 18 and ≤ 28 kg/m^2 at screening.
- No clinically significant findings on the physical examination at screening.
- Systolic blood pressure (SBP) 100-145 mmHg and diastolic blood pressure (DBP) 50-90 mmHg, measured on the dominant arm, after 5 min in the supine position at screening and Day -1 of pilot phase/ first treatment period in main phase.
- 12-lead ECG without clinically relevant abnormalities at screening and Day -1 pilot phase / first treatment period in main phase.
- Negative results from urine drug screen at screening and Day -1 pilot phase / first treatment period in main phase.
- Hematology and clinical chemistry variables not deviating from the normal range to a clinically relevant extent 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 allergic reactions or hypersensitivity to the active compound or any excipients of the drug formulation(s).
- 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture or veins with a tendency to rupture during or after puncture).
- Heart rate < 50 or > 95 beats per minute (bpm) at screening or Day -1 of pilot phase / first treatment period in main phase on 12-lead ECG measured after 5 min in the supine position.
- PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) > 200 ms at screening and Day -1 of pilot phase / first treatment period in main phase.
- Subjects with personal or family history of long QT (time interval from beginning of the Q wave until end of the T wave) syndrome or hypokalemia.
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- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Previous exposure to the study medication within 3 months prior to screening.
- Any immunosuppressive treatment within 6 weeks or 5 half-lives of the drug, whichever is longer, before study drug administration.
- Treatment with another investigational drug within 3 months or 10 half-lives of the drug, whichever is longer, prior to screening or participation in more than 4 investigational drug studies within 1 year 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 (7 cups of coffee or 14 cups of tea) per day at screening.
- Smoking within the last 3 months prior to screening and inability to refrain from smoking during the course of the study.
- Treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines) within 2 weeks prior to screening.
- Loss of 250 mL or more of blood within 3 months prior to screening.
- Lymphopenia (< 1000 cells/μL) at screening or Day -1 of pilot phase / first treatment period in main phase.
- Viral, fungal (with exception of onychomycosis and dermatomycosis), bacterial, or protozoal infection within 4 weeks before the first study drug administration.
- Positive results from the hepatitis serology, except for vaccinated subjects or subjects with past but resolved hepatitis, at screening.
- Positive results from the human immunodeficiency virus (HIV) 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects
This study consists of a single-dose pilot phase and a randomized, two-way crossover, single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod formulation. Three subjects will be included in the pilot phase and 12 subjects in the main crossover phase.
- Conditions
- Healthy
- Being tested
- Ponesimod 5mg i.v., Ponesimod i.v., Ponesimod 10 mg tablet
- Keywords
- Ponesimod, Bioavailability, Pharmacokinetics, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponesimod 5mg i.v.Drug
Ponesimod i.v.Drug
Dose and infusion rate will be adjusted according to the results of the pilot phase
Ponesimod 10 mg tabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Pilot Phase | Experimental | Subjects will receive a single intravenous (i.v.) dose of 5 mg ponesimod dissolved in 50 mL sterile 0.9% sodium chloride (NaCl) solution as a 3-hour infusion in the fasted state in the morning (infusion rate: 0.028 mg/min). Receives: Drug: Ponesimod 5mg i.v. |
| Treatment A/Treatment B | Experimental | Subjects will receive Treatment A followed by Treatment B.
Treatment A: a single i.v. dose of ponesimod administered in the fasted state in the morning.
Treatment B: a single oral dose of ponesimod (10 mg) administered as 1 tablet in the fasted state in the morning.
There will be a washout period between doses of 12-15 days. Receives: Drug: Ponesimod i.v.; Drug: Ponesimod 10 mg tablet |
| Treatment B/Treatment A | Experimental | Subjects will receive Treatment B followed by Treatment A.
Treatment A: a single i.v. dose of ponesimod administered in the fasted state in the morning.
Treatment B: a single oral dose of ponesimod (10 mg) administered as 1 tablet in the fasted state in the morning.
There will be a washout period between doses of 12-15 days. Receives: Drug: Ponesimod i.v.; Drug: Ponesimod 10 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC(0-144h)) of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. AUC(0-144) will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification.
Measured: 7 Days
Area under the plasma concentration-time curve (AUC(0-infinity)) of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. AUC(0-infinity) will be calculated by combining AUC(0-144) and AUC(extra). AUC(extra) represents an extrapolated value obtained by Ct/λz, where Ct is the last plasma concentration measured above the limit of quantification and λz represents the terminal elimination rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal elimination phase.
Measured: 7 Days
Maximum plasma concentration (Cmax) of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. Cmax will be calculated on the basis of the blood sampling time points.
Measured: 7 Days
Plasma half life (t1/2) of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. t1/2 will be calculated on the basis of the blood sampling time points.
Measured: 7 Days
Time to maximum plasma concentration (tmax) after oral administration of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. tmax will be calculated on the basis of the blood sampling time points.
Measured: 7 Days
Total body clearance (CL) after intravenous administration of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. CL Total body clearance will be calculated as follows: CL = Dose / AUC(0-infinity).
Measured: 7 Days
Volume of distribution (Vss) after intravenous administration of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. Vss will be estimated by CL [(AUMC/AUC) - (infusion time/2)], where AUMC is the area under the first moment curve.
Measured: 7 Days
Absolute bioavailability (F) of after oral administration of ponesimod
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. F will be calculated using the geometric means (as derived by the mixed effect model) of AUC(0-infinity).
Measured: 7 Days
Secondary outcomes (10)
Change from baseline up to Day 7 in systolic blood pressure
Blood pressure (systolic and diastolic) and pulse rate will be measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements will be recorded in the supine position after the subject has rested for a 5-minute period.
Measured: 7 Days
Change from baseline up to Day 7 in diastolic blood pressure
Blood pressure (systolic and diastolic) and pulse rate will be measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements will be recorded in the supine position after the subject has rested for a 5-minute period.
Measured: 7 Days
Change from baseline up to Day 7 in pulse rate
Blood pressure (systolic and diastolic) and pulse rate will be measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm = writing arm). Measurements will be recorded in the supine position after the subject has rested for a 5-minute period.
Measured: 7 Days
Change from baseline up to Day 7 in heart rate
Heart rate will be determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.
Measured: 7 Days
Change from baseline up to Day 7 in PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex)
PR interval will be determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.
Measured: 7 Days
Change from baseline up to Day 7 in QRS duration (time interval from the beginning of the Q wave to the end of the S wave)
QRS duration will be determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.
Measured: 7 Days
Change from baseline up to Day 7 in QT interval (time interval from beginning of the Q wave until end of the T wave)
QT interval will be determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.
Measured: 7 Days
Change from baseline up to Day 7 in QT interval according to Bazett's correction (QTcB)
QTcB interval will be determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting. The QTcB interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Bazett's formula (QTcB = QT/RR^0.5 where RR is 60/heart rate)
Measured: 7 Days
Change from baseline up to Day 7 in QT interval according to Fridericia's correction (QTcF)
QTcF interval will be determined from standard 12-lead electrocardiographs (ECGs) recorded in the supine position, after a 5-minute period of resting.The QTcF interval is the QT interval (interval from beginning of the Q wave until end of the T wave) corrected for heart rate with Fridericia's formula (QTcB = QT/RR^0.33 where RR is 60/heart rate)
Measured: 7 Days
Frequency of treatment-emergent ECG abnormalities from up to Day 7
Treatment-emergent abnormalities will be determined from standard 12-lead ECGs recorded in the supine position, after a 5-minute period of resting. Treatment-emergent ECG abnormalities are any ECG abnormalities that occur up to 144 hours after each study drug administration.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniela Baldoni, PharmD, PhD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068235
- Sponsor's protocol ID
- AC-058-114
- Status last verified
- May 2015
- First submitted
- 19 Feb 2014
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02068235
- Acronym / sponsor ID
- AC-058-114
- Conditions
- Healthy
- Keywords
- Ponesimod, Bioavailability, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Feb 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.
This study consists of a single-dose pilot phase and a randomized, two-way crossover, single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of the oral formulation (tablet) of ponesimod compared to an intravenous (i.v.) ponesimod formulation. Three subjects will be included in the pilot phase and 12 subjects in the main crossover phase.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilot Phase | Experimental | Drug: Ponesimod 5mg i.v.Subjects will receive a single intravenous (i.v.) dose of 5 mg ponesimod dissolved in 50 mL sterile 0.9% sodium chloride (NaCl) solution as a 3-hour infusion in the fasted state in the morning (infusion rate: 0.028 mg/min). |
| Treatment A/Treatment B | Experimental | Drug: Ponesimod i.v., Drug: Ponesimod 10 mg tabletSubjects will receive Treatment A followed by Treatment B. Treatment A: a single i.v. dose of ponesimod administered in the fasted state in the morning. Treatment B: a single oral dose of ponesimod (10 mg) administered as 1 tablet in the fasted state in the morning. There will be a washout period between doses of 12-15 days. |
| Treatment B/Treatment A | Experimental | Drug: Ponesimod i.v., Drug: Ponesimod 10 mg tabletSubjects will receive Treatment B followed by Treatment A. Treatment A: a single i.v. dose of ponesimod administered in the fasted state in the morning. Treatment B: a single oral dose of ponesimod (10 mg) administered as 1 tablet in the fasted state in the morning. There will be a washout period between doses of 12-15 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent in the local language prior to any study-mandated procedure.
- Body mass index ≥ 18 and ≤ 28 kg/m^2 at screening.
- No clinically significant findings on the physical examination at screening.
- Systolic blood pressure (SBP) 100-145 mmHg and diastolic blood pressure (DBP) 50-90 mmHg, measured on the dominant arm, after 5 min in the supine position at screening and Day -1 of pilot phase/ first treatment period in main phase.
- 12-lead ECG without clinically relevant abnormalities at screening and Day -1 pilot phase / first treatment period in main phase.
Key exclusion criteria (21 listed)
- Known allergic reactions or hypersensitivity to the active compound or any excipients of the drug formulation(s).
- 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture or veins with a tendency to rupture during or after puncture).
- Heart rate < 50 or > 95 beats per minute (bpm) at screening or Day -1 of pilot phase / first treatment period in main phase on 12-lead ECG measured after 5 min in the supine position.
- PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) > 200 ms at screening and Day -1 of pilot phase / first treatment period in main phase.
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 |
|---|---|---|
| Ponesimod 5mg i.v. | Drug | Pilot Phase |
| Ponesimod i.v.Dose and infusion rate will be adjusted according to the results of the pilot phase | Drug | Treatment A/Treatment B, Treatment B/Treatment A |
| Ponesimod 10 mg tablet | Drug | Treatment A/Treatment B, Treatment B/Treatment A |
Primary outcome
Area under the plasma concentration-time curve (AUC(0-144h)) of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. AUC(0-144) will be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification.
Area under the plasma concentration-time curve (AUC(0-infinity)) of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. AUC(0-infinity) will be calculated by combining AUC(0-144) and AUC(extra). AUC(extra) represents an extrapolated value obtained by Ct/λz, where Ct is the last plasma concentration measured above the limit of quantification and λz represents the terminal elimination rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal elimination phase.
Maximum plasma concentration (Cmax) of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. Cmax will be calculated on the basis of the blood sampling time points.
Plasma half life (t1/2) of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. t1/2 will be calculated on the basis of the blood sampling time points.
Time to maximum plasma concentration (tmax) after oral administration of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. tmax will be calculated on the basis of the blood sampling time points.
Total body clearance (CL) after intravenous administration of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. CL Total body clearance will be calculated as follows: CL = Dose / AUC(0-infinity).
Volume of distribution (Vss) after intravenous administration of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. Vss will be estimated by CL [(AUMC/AUC) - (infusion time/2)], where AUMC is the area under the first moment curve.
Absolute bioavailability (F) of after oral administration of ponesimod
Time frame: 7 Days
Blood samples for pharmacokinetic analysis will be taken immediately prior to dosing with ponesimod, and at various time points up to 7 days after dosing. F will be calculated using the geometric means (as derived by the mixed effect model) of AUC(0-infinity).
10 secondary outcomes
Change from baseline up to Day 7 in systolic blood pressure
Time frame: 7 Days
Change from baseline up to Day 7 in diastolic blood pressure
Time frame: 7 Days
Change from baseline up to Day 7 in pulse rate
Time frame: 7 Days
Change from baseline up to Day 7 in heart rate
Time frame: 7 Days
Change from baseline up to Day 7 in PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex)
Time frame: 7 Days
Change from baseline up to Day 7 in QRS duration (time interval from the beginning of the Q wave to the end of the S wave)
Time frame: 7 Days
Change from baseline up to Day 7 in QT interval (time interval from beginning of the Q wave until end of the T wave)
Time frame: 7 Days
Change from baseline up to Day 7 in QT interval according to Bazett's correction (QTcB)
Time frame: 7 Days
Change from baseline up to Day 7 in QT interval according to Fridericia's correction (QTcF)
Time frame: 7 Days
Frequency of treatment-emergent ECG abnormalities from up to Day 7
Time frame: 7 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 21 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.
Daniela Baldoni, PharmD, 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 Ponesimod 5mg i.v., Ponesimod i.v. and Ponesimod 10 mg tablet in people with Healthy, run by Actelion at 1 site in United Kingdom.
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 8 inclusion and 21 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 21 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 United Kingdom. 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?
Area under the plasma concentration-time curve (AUC(0-144h)) of ponesimod (time frame: 7 Days). The study lists 8 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 21 May 2015.