Clinical trial NCT03836222: Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Processa Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2019-02-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. Male or non-pregnant, non-lactating female subjects
2. Aged 18 to 55 years, inclusive
3. 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
4. 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
5. Subjects who were willing and able to be confined at the clinical research centre for the scheduled inpatient visits
6. Ability to swallow multiple tablets whole

Exclusion Criteria:

1. 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
2. Subject had a known or suspected malignancy with the exception of basal cell carcinoma
3. 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
4. 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).
5. Subject had active disease or symptoms within 7 days prior to Day -1, such as nausea, vomiting, diarrhoea, and infection
6. Subject had undergone a hospital admission or major surgery within 30 days prior to the Screening visit
7. Subjects who had taken part in Part 1 were not permitted to take part in Part 2

Primary outcomes:
measure: Maximum plasma concentrations (Cmax) for Part 1
timeFrame: Blood samples will be drawn prior to single dose administration of study drug and at 11 other timepoints in a 24 hour period.
measure: Maximum plasma concentrations (Cmax) in Part 2
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Quotient Sciences
name: Sharan Sidhu, MBChB
role: PRINCIPAL_INVESTIGATOR
References: