HealthyPhase 1NCT03836222
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
A Phase 1 study testing PCS499 and Trental in people with Healthy, run by Processa Pharmaceuticals at 1 site in United Kingdom.
Trial summary
This was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PCS499 and Trental
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2018to 4 Jun 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-pregnant, non-lactating female subjects
- Aged 18 to 55 years, inclusive
- Subjects who were healthy as determined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead resting electrocardiogram (ECG; corrected QT interval [QTc] ≤450, QRS <120, PR <220; normal morphology) performed at the screening visit and prior to each dosing
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 inclusive or, if outside the range, considered not clinically significant by the investigator and body weight >50 kg
- Subjects who were willing and able to be confined at the clinical research centre for the scheduled inpatient visits
- Ability to swallow multiple tablets whole
Who cannot join
- Subject had a clinically significant history of GI, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders and/or drug hypersensitivity
- Subject had a known or suspected malignancy with the exception of basal cell carcinoma
- Subject had a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at the screening visit
- Female subjects who were pregnant or lactating (all female subjects required a negative serum pregnancy test at the screening and a negative urine pregnancy test at each admission).
- Subject had active disease or symptoms within 7 days prior to Day -1, such as nausea, vomiting, diarrhoea, and infection
- Subject had undergone a hospital admission or major surgery within 30 days prior to the Screening visit
- Subjects who had taken part in Part 1 were not permitted to take part in Part 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single Centre, Open-Label, Non-Randomised Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® (Pentoxifylline) Administered to Healthy Subjects Under Fed Conditions
This was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.
- Conditions
- Healthy
- Being tested
- PCS499, Trental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCS499Drug
MR tablet
TrentalDrug
comparator tablet
| Study group | Role | What they receive |
|---|---|---|
| PCS499 MR Tablet Prototype 2 | Experimental | 600 mg single dose Receives: Drug: PCS499 |
| Trental MR tablet 400mg | Active comparator | single dose Receives: Drug: Trental |
| PCS499 MR Tablet Prototype 4 | Experimental | 600mg single dose Receives: Drug: PCS499 |
| PCS499 MR Tablet Prototype 1 | Experimental | 600mg single dose Receives: Drug: PCS499 |
| Trental MR Tablet | Active comparator | 400 mg multiple dose Receives: Drug: Trental |
| PCS499 MR Tablet 900mg | Experimental | multiple dose Receives: Drug: PCS499 |
| PCS499 MR Tablet 600mg | Experimental | multiple dose Receives: Drug: PCS499 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentrations (Cmax) for Part 1
Serial blood sampling at specified time points for determination of plasma concentration-time profiles
Measured: Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.
Maximum plasma concentrations (Cmax) in Part 2
Serial blood sampling at specified time points for determination of plasma concentration-time profiles
Measured: Blood sampling will be drawn prior to the single dose administration on Days 1 & 4 and at 11 other timepoints in the following 24 hours. In addition, pre-dose trough samples will be taken on Days 2 &3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start26 Feb 2018
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Processa Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Sharan Sidhu, MBChB, Principal investigator, Quotient Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836222
- Sponsor's protocol ID
- PCS499.1005
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Centre, Open-Label, Non-Randomised Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® (Pentoxifylline) Administered to Healthy Subjects Under Fed Conditions
- ClinicalTrials.gov ID
- NCT03836222
- Acronym / sponsor ID
- PCS499.1005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Processa PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 11 Feb 2019 (actual)
- 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 Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| PCS499 MR Tablet Prototype 2 | Experimental | Drug: PCS499600 mg single dose |
| Trental MR tablet 400mg | Active comparator | Drug: Trentalsingle dose |
| PCS499 MR Tablet Prototype 4 | Experimental | Drug: PCS499600mg single dose |
| PCS499 MR Tablet Prototype 1 | Experimental | Drug: PCS499600mg single dose |
| Trental MR Tablet | Active comparator | Drug: Trental400 mg multiple dose |
| PCS499 MR Tablet 900mg | Experimental | Drug: PCS499multiple dose |
| PCS499 MR Tablet 600mg | Experimental | Drug: PCS499multiple dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or non-pregnant, non-lactating female subjects
- Aged 18 to 55 years, inclusive
- Subjects who were healthy as determined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead resting electrocardiogram (ECG; corrected QT interval [QTc] ≤450, QRS <120, PR <220; normal morphology) performed at the screening visit and prior to each dosing
- Body mass index (BMI) of 18.0 to 35.0 kg/m2 inclusive or, if outside the range, considered not clinically significant by the investigator and body weight >50 kg
- Subjects who were willing and able to be confined at the clinical research centre for the scheduled inpatient visits
Key exclusion criteria (7 listed)
- Subject had a clinically significant history of GI, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, and/or lipid metabolism disorders and/or drug hypersensitivity
- Subject had a known or suspected malignancy with the exception of basal cell carcinoma
- Subject had a positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCV Ab) at the screening visit
- Female subjects who were pregnant or lactating (all female subjects required a negative serum pregnancy test at the screening and a negative urine pregnancy test at each admission).
- Subject had active disease or symptoms within 7 days prior to Day -1, such as nausea, vomiting, diarrhoea, and infection
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 |
|---|---|---|
| PCS499MR tablet | Drug | PCS499 MR Tablet 600mg, PCS499 MR Tablet 900mg, PCS499 MR Tablet Prototype 1, PCS499 MR Tablet Prototype 2, PCS499 MR Tablet Prototype 4 |
| Trentalcomparator tablet | Drug | Trental MR Tablet, Trental MR tablet 400mg |
Primary outcome
Maximum plasma concentrations (Cmax) for Part 1
Time frame: Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.
Serial blood sampling at specified time points for determination of plasma concentration-time profiles
Maximum plasma concentrations (Cmax) in Part 2
Time frame: Blood sampling will be drawn prior to the single dose administration on Days 1 & 4 and at 11 other timepoints in the following 24 hours. In addition, pre-dose trough samples will be taken on Days 2 &3.
Serial blood sampling at specified time points for determination of plasma concentration-time profiles
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 12 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Sharan Sidhu, MBChB principal investigator
Quotient Sciences
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 PCS499 and Trental in people with Healthy, run by Processa Pharmaceuticals 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 6 inclusion and 7 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 12 Feb 2019. 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?
Maximum plasma concentrations (Cmax) for Part 1 (time frame: Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.