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

Sponsor

Processa Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03836222

Collaborator

Quotient Sciences (Industry)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PCS499 Drug: Trental	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Feb 26, 2018

Actual Primary Completion Date :

Jun 4, 2018

Actual Study Completion Date :

Jun 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PCS499 MR Tablet Prototype 2 600 mg single dose	Drug: PCS499 MR tablet
Active Comparator: Trental MR tablet 400mg single dose	Drug: Trental comparator tablet
Experimental: PCS499 MR Tablet Prototype 4 600mg single dose	Drug: PCS499 MR tablet
Experimental: PCS499 MR Tablet Prototype 1 600mg single dose	Drug: PCS499 MR tablet
Active Comparator: Trental MR Tablet 400 mg multiple dose	Drug: Trental comparator tablet
Experimental: PCS499 MR Tablet 900mg multiple dose	Drug: PCS499 MR tablet
Experimental: PCS499 MR Tablet 600mg multiple dose	Drug: PCS499 MR tablet

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences	Ruddington	Nottingham	United Kingdom

Sponsors and Collaborators

Processa Pharmaceuticals
Quotient Sciences

Investigators

Principal Investigator: Sharan Sidhu, MBChB, Quotient Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Processa Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03836222

Other Study ID Numbers:

PCS499.1005

First Posted:

Feb 11, 2019

Last Update Posted:

Feb 12, 2019

Last Verified:

Feb 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pentoxifylline

Study Results

No Results Posted as of Feb 12, 2019