Safety and TolerabilityPhase 1NCT02029482
Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-128800 in Healthy Subjects
A Phase 1 study testing ACT-128800 in people with Safety and Tolerability, run by Actelion at 1 site in United Kingdom.
Trial summary
This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1 study. Sixteen subjects in two groups (at least 40% of subjects of either male or female sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg, and 4 subjects in the placebo… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- ACT-128800
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2010to Jun 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent in the local language prior to any study-mandated procedure.
- Age between 18 and 65 years (inclusive) at screening.
- Body mass index (BMI) between 18 and 30 kg/m^2 (inclusive).
- Women of childbearing potential were required to have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to first drug intake and have agreed to use two methods of contraception from the screening visit until 2 months after study drug discontinuation.
- Systolic blood pressure 100-150 mmHg, diastolic blood pressure 50-90 mmHg measured on the leading arm, and heart rate 50-95 beats per minute (inclusive) measured by electrocardiography (ECG) after 5 minutes in the supine position at screening.
- ECG without clinically relevant abnormalities at screening.
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- 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 and to understand and comply with the requirements of the study.
Who cannot join
- ECG recording; PQ/PR interval > 200 ms at screening.
- Pregnant or lactating women.
- Known hypersensitivity to any excipients of the drug formulation.
- Known hypersensitivity to beta2 adrenergic receptor agonists.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Treatment with another investigational drug within 3 months prior to screening.
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- 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 that might interfere with the absorption, distribution, metabolism or excretion of the study drug.
- 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 (including herbal medicines such as St John's Wort) within 2 weeks prior to screening or 5 half-lives of the drug, whichever is longer.
- Loss of 250 mL or more of blood within 3 months prior to screening.
- Lymphopenia (< 1,000 cells/μL).
- Viral, fungal, bacterial or protozoal infection within 4 weeks before study drug administration (e.g., active herpes and/or cytomegalovirus infection).
- History or clinical evidence suggestive of active or latent tuberculosis at screening.
- Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- Positive results from the human immunodeficiency virus serology at screening.
- Forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) < 80% of the predicted value, or FEV1/FVC ratio < 0.7 at screening.
- History of asthma or chronic obstructive pulmonary disease.
- Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the subject in the standard 12-lead ECG and 24-hour 3-lead Holter ECG at screening.
- History of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Familial history of sick-sinus syndrome.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. Alcohol abuse is defined as regular weekly intake of more than 21 units.
- Legal incapacity or limited legal capacity at screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quintiles Drug Research Unit at Guy's Hospital
London, SE1 1YR
About this study
Official title: Single-center, Double-blind, Placebo-controlled, Randomized, Parallel-group, Up-titration Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Increasing Doses of ACT-128800 in Healthy Male and Female Subjects
This was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1 study. Sixteen subjects in two groups (at least 40% of subjects of either male or female sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg.
- Conditions
- Safety and Tolerability
- Being tested
- ACT-128800, Placebo
- Keywords
- ACT-128800
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-128800Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ACT-128800 | Experimental | ACT-128800 tablets, once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg. Receives: Drug: ACT-128800 |
| Placebo | Placebo comparator | Matching placebo tablets, once daily, for 18 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Day 18 in systolic blood pressure
Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand).
Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Measured: 18 days
Change from baseline to Day 18 in diastolic blood pressure
Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand).
Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Measured: 18 days
Change from baseline to Day 18 in pulse rate
Pulse rate was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand).
Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Measured: 18 days
Change from baseline to Day 18 in body temperature
Body temperature was measured in the supine position using the same thermometer throughout the study.
Measured: 18 days
Secondary outcomes (23)
Change from baseline to Day 10 in mean absolute lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte counts were determined with standard commercially available assay kits.
Measured: 10 days
Change from baseline to Day 10 in mean T cell (Cluster of differentiation (CD) CD3+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean B cell (CD3-/CD19+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean natural killer (NK) cell (CD3-/CD56+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean natural killer T (NKT) cell (CD3+/CD56+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD4+ T-helper cell (CD3+/CD4+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean T-cytotoxic cell (CD3+/CD8+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD4+T-naive cell (CD45RA+/chemokine receptor type 7 (CCR7+)) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD4+ T-central memory cell (CD45RA-/CCR7+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD4+ T-effector memory cell (CD45RA-/CCR7-) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD4+ T-effector cell (CD45RA+/CCR7-) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD8+ T-naive cell (CD45RA+/CCR7+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD8+ T-central memory cell (CD45RA-/CCR7+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD8+ T-effector memory cell (CD45RA-/CCR7-) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean CD8+ T-effector cell (CD45RA+/CCR7-) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean T-regulatory cell (CD25+/Forkhead box P3 (Foxp3+)) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean skin-homing T-helper cell (Cutaneous lymphocyte antigen (CLA)+/integrin β7-) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Change from baseline to Day 10 in mean gut-homing T-helper cell (CLA-/integrin β7+) lymphocyte count
For each assessment, 1.5 mL of blood was collected aseptically from the subject in the supine position by venipuncture or via an intravenous. catheter placed in an antecubital vein in the arm in ethylenediaminetetraacetic acid containing tubes. Immediately following collection of the required whole blood volume, the tubes were slowly tilted backwards and forwards (no shaking) to bring the anti-coagulant into solution. The anticoagulated whole blood stored at room temperature (20-25 °C) was preferably stained within 12 hours, at the latest 24 hours, and analyzed within 24 hours. The lymphocyte subset counts were analyzed by fluorescence activated cell sorting.
Measured: 10 days
Maximum plasma concentration (Cmax) of ACT-128800 on Days 9 and 18
Blood samples for pharmacokinetic analysis were taken following drug administration on study Day 9 (Day 3 of the dosing period with 40 mg) and study Day 18 (Day 3 of the dosing period with 100 mg) and Cmax of ACT-128800 was determined by non-compartmental analysis.
Measured: 18 days
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24) of ACT-128800 on Days 9 and 18
Blood samples for pharmacokinetic analysis were taken following drug administration on study Day 9 (Day 3 of the dosing period with 40 mg) and study Day 18 (Day 3 of the dosing period with 100 mg) and AUC0-24 of ACT-128800 was determined by non-compartmental analysis.
Measured: 18 days
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-infinity) of ACT-128800 on Day 18
Blood samples for pharmacokinetic analysis were taken following drug administration on study Day 18 (Day 3 of the dosing period with 100 mg) and AUC0-infinity of ACT-128800 was determined by non-compartmental analysis.
Measured: 18 days
Time to reach maximum plasma concentration (tmax) of ACT-128800 on Days 9 and 18
Blood samples for pharmacokinetic analysis were taken following drug administration on study Day 9 (Day 3 of the dosing period with 40 mg) and study Day 18 (Day 3 of the dosing period with 100 mg) and tmax of ACT-128800 was determined by non-compartmental analysis.
Measured: 18 days
Terminal half-life (t1/2) of ACT-128800 on Day 18
Blood samples for pharmacokinetic analysis were taken following drug administration on study Day 18 (Day 3 of the dosing period with 100 mg) and t1/2 of ACT-128800 was determined by non-compartmental analysis.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, MBBS, DCPSA, Principal investigator, Quintiles Drug Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029482
- Sponsor's protocol ID
- AC-058-109
- Status last verified
- Jan 2014
- First submitted
- 6 Jan 2014
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Double-blind, Placebo-controlled, Randomized, Parallel-group, Up-titration Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Increasing Doses of ACT-128800 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02029482
- Acronym / sponsor ID
- AC-058-109
- Conditions
- Safety and Tolerability
- Keywords
- ACT-128800
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Jan 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 was a single-center, randomized, double-blind, placebo-controlled, up-titration Phase 1 study. Sixteen subjects in two groups (at least 40% of subjects of either male or female sex), with 12 subjects in the active treatment group with an up-titration scheme from 10 to 100 mg, and 4 subjects in the placebo treatment group. Subjects were administered ascending doses of ACT-128800/placebo once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-128800 | Experimental | Drug: ACT-128800ACT-128800 tablets, once daily for 3 days at each dose level: 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablets, once daily, for 18 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent in the local language prior to any study-mandated procedure.
- Age between 18 and 65 years (inclusive) at screening.
- Body mass index (BMI) between 18 and 30 kg/m^2 (inclusive).
- Women of childbearing potential were required to have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to first drug intake and have agreed to use two methods of contraception from the screening visit until 2 months after study drug discontinuation.
- Systolic blood pressure 100-150 mmHg, diastolic blood pressure 50-90 mmHg measured on the leading arm, and heart rate 50-95 beats per minute (inclusive) measured by electrocardiography (ECG) after 5 minutes in the supine position at screening.
Key exclusion criteria (24 listed)
- ECG recording; PQ/PR interval > 200 ms at screening.
- Pregnant or lactating women.
- Known hypersensitivity to any excipients of the drug formulation.
- Known hypersensitivity to beta2 adrenergic receptor agonists.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
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 |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline to Day 18 in systolic blood pressure
Time frame: 18 days
Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Change from baseline to Day 18 in diastolic blood pressure
Time frame: 18 days
Blood pressure was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Change from baseline to Day 18 in pulse rate
Time frame: 18 days
Pulse rate was measured using an automatic oscillometric device, always on the leading arm (i.e., leading arm right = writing with right hand). Measurements were recorded from the subject in the supine position after having rested for a 5-minute period.
Change from baseline to Day 18 in body temperature
Time frame: 18 days
Body temperature was measured in the supine position using the same thermometer throughout the study.
23 secondary outcomes
Change from baseline to Day 10 in mean absolute lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean T cell (Cluster of differentiation (CD) CD3+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean B cell (CD3-/CD19+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean natural killer (NK) cell (CD3-/CD56+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean natural killer T (NKT) cell (CD3+/CD56+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD4+ T-helper cell (CD3+/CD4+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean T-cytotoxic cell (CD3+/CD8+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD4+T-naive cell (CD45RA+/chemokine receptor type 7 (CCR7+)) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD4+ T-central memory cell (CD45RA-/CCR7+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD4+ T-effector memory cell (CD45RA-/CCR7-) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD4+ T-effector cell (CD45RA+/CCR7-) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD8+ T-naive cell (CD45RA+/CCR7+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD8+ T-central memory cell (CD45RA-/CCR7+) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD8+ T-effector memory cell (CD45RA-/CCR7-) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean CD8+ T-effector cell (CD45RA+/CCR7-) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean T-regulatory cell (CD25+/Forkhead box P3 (Foxp3+)) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean skin-homing T-helper cell (Cutaneous lymphocyte antigen (CLA)+/integrin β7-) lymphocyte count
Time frame: 10 days
Change from baseline to Day 10 in mean gut-homing T-helper cell (CLA-/integrin β7+) lymphocyte count
Time frame: 10 days
Maximum plasma concentration (Cmax) of ACT-128800 on Days 9 and 18
Time frame: 18 days
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC0-24) of ACT-128800 on Days 9 and 18
Time frame: 18 days
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-infinity) of ACT-128800 on Day 18
Time frame: 18 days
Time to reach maximum plasma concentration (tmax) of ACT-128800 on Days 9 and 18
Time frame: 18 days
Terminal half-life (t1/2) of ACT-128800 on Day 18
Time frame: 18 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 8 Jan 2014.
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Neoplasms
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.
Darren Wilbraham, MBBS, DCPSA principal investigator
Quintiles Drug Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-128800 in people with Safety and Tolerability, 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 9 inclusion and 24 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 8 Jan 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 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. Some participants in this study may receive a placebo. 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 from baseline to Day 18 in systolic blood pressure (time frame: 18 days). The study lists 4 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 8 Jan 2014.