Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
- Registration Number
- NCT03836222
- Lead Sponsor
- Processa Pharmaceuticals
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Trental MR tablet 400mg Trental single dose Trental MR Tablet Trental 400 mg multiple dose PCS499 MR Tablet Prototype 2 PCS499 600 mg single dose PCS499 MR Tablet Prototype 4 PCS499 600mg single dose PCS499 MR Tablet Prototype 1 PCS499 600mg single dose PCS499 MR Tablet 600mg PCS499 multiple dose PCS499 MR Tablet 900mg PCS499 multiple dose
- Primary Outcome Measures
Name Time Method Maximum plasma concentrations (Cmax) in Part 2 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
Maximum plasma concentrations (Cmax) for Part 1 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Ruddington, Nottingham, United Kingdom