Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects

Processa Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Trental; Drug: PCS499

Study type: Interventional

Funder types: Industry

Identifiers

NCT03836222

PCS499.1005

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 7 patient groups

PCS499 MR Tablet Prototype 2

Experimental group

Description:

600 mg single dose

Treatment:

Drug: PCS499

Trental MR tablet 400mg

Active Comparator group

Description:

single dose

Treatment:

Drug: Trental

PCS499 MR Tablet Prototype 4

Experimental group

Description:

600mg single dose

Treatment:

Drug: PCS499

PCS499 MR Tablet Prototype 1

Experimental group

Description:

600mg single dose

Treatment:

Drug: PCS499

Trental MR Tablet

Active Comparator group

Description:

400 mg multiple dose

Treatment:

Drug: Trental

PCS499 MR Tablet 900mg

Experimental group

Description:

multiple dose

Treatment:

Drug: PCS499

PCS499 MR Tablet 600mg

Experimental group

Description:

multiple dose

Treatment:

Drug: PCS499