HealthyPhase 1NCT02223832
Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
A Phase 1 study testing ACT-128800 in people with Healthy, run by Actelion at 1 site in United States.
Trial summary
This is a study to evaluate the relative pharmacokinetic properties and the tolerability and safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after single-dose administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent prior to any study-mandated procedure.
- Japanese or Caucasian. (Japanese subjects: both parents of the subject are Japanese [born in Japan]. Caucasian subjects: both parents of the subject are Caucasian).
- Body mass index between 18 and 28 kg/m^2, inclusive.
- Women not of childbearing potential:
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to drug intake on Day 1; use a reliable method of contraception and continue this contraception for the duration of the study and for at least 2 months after study drug intake. In addition, her partner must use a condom.
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart rate (HR) 50-95 beats per minute (inclusive).
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- 12-lead electrocardiogram without clinically relevant abnormalities at screening.
- Hematology and clinical chemistry 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 (if necessary with the help of an interpreter) and to understand and comply with the requirements of the study.
Who cannot join
- Electrocardiograph PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) > 200 milliseconds at screening.
- Nursing woman.
- History of asthma or chronic obstructive pulmonary disease.
- Known hypersensitivity to any excipients of the drug formulation.
- Treatment with another investigational drug within 3 months prior to screening.
- Excessive caffeine consumption, defined as > 800 mg per day at screening.
Show all 19Show fewer
- History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- Any cardiac condition or illness, including ECG abnormalities, with a potential to increase the cardiac risk of the subject.
- Smoking within the last month prior to screening.
- Any immunosuppressive treatment within 6 weeks before study drug administration.
- Previous treatment with any prescribed or over-the-counter medications within 2 weeks prior to screening.
- Loss of 250 mL or more of blood within 3 months prior to screening.
- Lymphopenia (< 1,000 lymphocytes/μL).
- Viral, fungal, bacterial or protozoal infection within 4 weeks before study drug administration.
- Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- Positive results from human immunodeficiency vrus serology at screening.
- Legal incapacity or limited legal capacity at screening.
- History of alcoholism or drug abuse.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hawaii Clinical Research Center
Honolulu, Hawaii, 96813
About this study
Official title: Single-center, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of 40 mg ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
This is a study to evaluate the relative pharmacokinetic properties and the tolerability and safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after single-dose administration.
Read the detailed description
10 Japanese and 10 Caucasian healthy male and female subjects in a one to one male to female ratio will be included in the study. Japanese and Caucasian subjects will be matched for body weight.
- Conditions
- Healthy
- Being tested
- ACT-128800
- Keywords
- ACT-128800, Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-128800Drug
| Study group | Role | What they receive |
|---|---|---|
| ACT-128800 | Experimental | A single oral dose of 40 mg ACT-128800 will be administered as
1 capsule given in the fasted state in the morning Receives: Drug: ACT-128800 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure from baseline up to end of study
Blood pressure shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Measured: Up to 10 days
Change in diastolic blood pressure from baseline up to end of study
Blood pressure shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Measured: Up to 10 days
Change in pulse rate from baseline up to end of study
Pulse rate shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Measured: Up to 10 days
Change in body temperature from baseline up to end of study
Body temperature shall be measured in a supine position using the same thermometer throughout the study.
Measured: Up to 10 days
Change in forced expiratory volume in 1 second (FEV1) from baseline up to end of study
FEV1 assessments shall be performed in a standardized manner as per the American Thoracic Society standards. Three good test breaths will be measured; the highest FEV1 value from these three breath tests will be recorded.
Measured: Up to 10 days
Change in forced vital capacity (FVC) from baseline up to end of study
FVC assessments shall be performed in a standardized manner as per the American Thoracic Society standards. Three good test breaths will be measured; the highest FVC value from these three breath tests will be recorded.
Measured: Up to 10 days
Number of treatment-emergent abnormalities on physical examination up to end of study
Physical examination (i.e., inspection, percussion, palpation, and auscultation) shall be performed during the course of the study.
Measured: Up to 10 days
Change in heart rate from baseline up to end of study
Heart rate shall be measured using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period.
Measured: Up to 10 days
Change in QT interval (time interval from beginning of the Q wave until end of the T wave) calculated according to Bazett's correction (QTcB) from baseline up to end of study
QTcB shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period. The QTcB interval is the QT interval corrected for heart rate with Bazett's formula (QTcB = QT/RR^0.5 where RR is 60/heart rate).
Measured: Up to 10 days
Change in QT interval (time interval from beginning of the Q wave until end of the T wave) calculated according to Fridericia's correction (QTcF) from baseline up to end of study
QTcF shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period. The QTcF interval is the QT interval corrected for heart rate with Fridericia's formula (QTcF = QT/RR^0.33 where RR is 60/heart rate).
Measured: Up to 10 days
Number of treatment-emergent electrocardiogram abnormalities up to end of study
Electrocardiogram abnormalities shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period.
Measured: Up to 10 days
Secondary outcomes (6)
Maximum plasma concentration (Cmax) of ACT-128800
Blood samples for pharmacokinetic analysis shall be taken immediately prior to dosing with ACT-128800 and at 0.5, 1, 1.5, 2.5, 4, 6, 10, 16, 24, 36, 48, 72, 96, 120 and 144 hours after dosing. Cmax will be calculated on the basis of the blood sampling time points.
Measured: 144 hours
Time to maximum plasma concentration (tmax) of ACT-128800
Blood samples for pharmacokinetic analysis shall be taken immediately prior to dosing with ACT-128800 and at 0.5, 1, 1.5, 2.5, 4, 6, 10, 16, 24, 36, 48, 72, 96, 120 and 144 hours after dosing. tmax will be calculated on the basis of the blood sampling time points.
Measured: 144 hours
Area under the plasma concentration-time curve (AUC(0-t)) of ACT-128800
Blood samples for pharmacokinetic analysis shall be taken immediately prior to dosing with ACT-128800 and at 0.5, 1, 1.5, 2.5, 4, 6, 10, 16, 24, 36, 48, 72, 96, 120 and 144 hours after dosing. AUC(0-t) shall be calculated according to the linear trapezoidal rule using the measured concentration-time values above the limit of quantification
Measured: 144 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of ACT-128800
Blood samples for pharmacokinetic analysis shall be taken immediately prior to dosing with ACT-128800 and at 0.5, 1, 1.5, 2.5, 4, 6, 10, 16, 24, 36, 48, 72, 96, 120 and 144 hours after dosing. AUC(0-infinity) will be calculated by combining AUC(0-t) 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: 144 hours
Plasma half life (t1/2) of ACT-128800
Blood samples for pharmacokinetic analysis shall be taken immediately prior to dosing with ACT-128800 and at 0.5, 1, 1.5, 2.5, 4, 6, 10, 16, 24, 36, 48, 72, 96, 120 and 144 hours after dosing. t1/2 will be calculated on the basis of the blood sampling time points.
Measured: 144 hours
Change in lymphocyte count from baseline up to end of study
At various time points up to the end of study about 3 mL of blood will be collected by venepuncture in the supine position, for the measurement of lymphocyte count.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startFeb 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Brossard, PhD, Study director, Actelion Pharmaceuticals Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223832
- Sponsor's protocol ID
- AC-058-107
- Status last verified
- Aug 2014
- First submitted
- 21 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label, Parallel-group Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of 40 mg ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02223832
- Acronym / sponsor ID
- AC-058-107
- Conditions
- Healthy
- Keywords
- ACT-128800, Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Aug 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 is a study to evaluate the relative pharmacokinetic properties and the tolerability and safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after single-dose administration.
Detailed description
10 Japanese and 10 Caucasian healthy male and female subjects in a one to one male to female ratio will be included in the study. Japanese and Caucasian subjects will be matched for body weight.
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-128800A single oral dose of 40 mg ACT-128800 will be administered as 1 capsule given in the fasted state in the morning |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent prior to any study-mandated procedure.
- Japanese or Caucasian. (Japanese subjects: both parents of the subject are Japanese [born in Japan]. Caucasian subjects: both parents of the subject are Caucasian).
- Body mass index between 18 and 28 kg/m^2, inclusive.
- Women not of childbearing potential:
- Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to drug intake on Day 1; use a reliable method of contraception and continue this contraception for the duration of the study and for at least 2 months after study drug intake. In addition, her partner must use a condom.
Key exclusion criteria (19 listed)
- Electrocardiograph PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) > 200 milliseconds at screening.
- Nursing woman.
- History of asthma or chronic obstructive pulmonary disease.
- Known hypersensitivity to any excipients of the drug formulation.
- Treatment with another investigational drug within 3 months prior to screening.
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-128800 | Drug | ACT-128800 |
Primary outcome
Change in systolic blood pressure from baseline up to end of study
Time frame: Up to 10 days
Blood pressure shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Change in diastolic blood pressure from baseline up to end of study
Time frame: Up to 10 days
Blood pressure shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Change in pulse rate from baseline up to end of study
Time frame: Up to 10 days
Pulse rate shall be measured using an automatic oscillometric device, always on the leading (writing) arm. Measurements shall be taken in the supine position after having rested for at least a 5 min period.
Change in body temperature from baseline up to end of study
Time frame: Up to 10 days
Body temperature shall be measured in a supine position using the same thermometer throughout the study.
Change in forced expiratory volume in 1 second (FEV1) from baseline up to end of study
Time frame: Up to 10 days
FEV1 assessments shall be performed in a standardized manner as per the American Thoracic Society standards. Three good test breaths will be measured; the highest FEV1 value from these three breath tests will be recorded.
Change in forced vital capacity (FVC) from baseline up to end of study
Time frame: Up to 10 days
FVC assessments shall be performed in a standardized manner as per the American Thoracic Society standards. Three good test breaths will be measured; the highest FVC value from these three breath tests will be recorded.
Number of treatment-emergent abnormalities on physical examination up to end of study
Time frame: Up to 10 days
Physical examination (i.e., inspection, percussion, palpation, and auscultation) shall be performed during the course of the study.
Change in heart rate from baseline up to end of study
Time frame: Up to 10 days
Heart rate shall be measured using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period.
Change in QT interval (time interval from beginning of the Q wave until end of the T wave) calculated according to Bazett's correction (QTcB) from baseline up to end of study
Time frame: Up to 10 days
QTcB shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period. The QTcB interval is the QT interval corrected for heart rate with Bazett's formula (QTcB = QT/RR^0.5 where RR is 60/heart rate).
Change in QT interval (time interval from beginning of the Q wave until end of the T wave) calculated according to Fridericia's correction (QTcF) from baseline up to end of study
Time frame: Up to 10 days
QTcF shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period. The QTcF interval is the QT interval corrected for heart rate with Fridericia's formula (QTcF = QT/RR^0.33 where RR is 60/heart rate).
Number of treatment-emergent electrocardiogram abnormalities up to end of study
Time frame: Up to 10 days
Electrocardiogram abnormalities shall be determined using standard 12-lead electrocardiogram recorded at rest with the subject in the supine position for a 5-minute period.
6 secondary outcomes
Maximum plasma concentration (Cmax) of ACT-128800
Time frame: 144 hours
Time to maximum plasma concentration (tmax) of ACT-128800
Time frame: 144 hours
Area under the plasma concentration-time curve (AUC(0-t)) of ACT-128800
Time frame: 144 hours
Area under the plasma concentration-time curve (AUC(0-infinity)) of ACT-128800
Time frame: 144 hours
Plasma half life (t1/2) of ACT-128800
Time frame: 144 hours
Change in lymphocyte count from baseline up to end of study
Time frame: Up to 10 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 22 Aug 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 Pharmaceuticals Limited
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 Healthy, run by Actelion 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 10 inclusion and 19 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 22 Aug 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 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?
Change in systolic blood pressure from baseline up to end of study (time frame: Up to 10 days). The study lists 11 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 22 Aug 2014.