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

NCT03836222 | Completed Phase 1

• 1 other identifier: PCS499.1005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Maximum plasma concentrations (Cmax) for Part 1

  Serial blood sampling at specified time points for determination of plasma concentration-time profiles

  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

  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.

Study Arms (7)

PCS499 MR Tablet Prototype 2

EXPERIMENTAL

600 mg single dose

Drug: PCS499

Trental MR tablet 400mg

ACTIVE COMPARATOR

single dose

Drug: Trental

PCS499 MR Tablet Prototype 4

EXPERIMENTAL

600mg single dose

Drug: PCS499

PCS499 MR Tablet Prototype 1

EXPERIMENTAL

600mg single dose

Drug: PCS499

Trental MR Tablet

ACTIVE COMPARATOR

400 mg multiple dose

Drug: Trental

PCS499 MR Tablet 900mg

EXPERIMENTAL

multiple dose

Drug: PCS499

PCS499 MR Tablet 600mg

EXPERIMENTAL

multiple dose

Drug: PCS499

Interventions

PCS499 DRUG

MR tablet

PCS499 MR Tablet 600mg; PCS499 MR Tablet 900mg; PCS499 MR Tablet Prototype 1; PCS499 MR Tablet Prototype 2; PCS499 MR Tablet Prototype 4

Trental DRUG

comparator tablet

Trental MR Tablet; Trental MR tablet 400mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Processa Pharmaceuticals: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Location

MeSH Terms

Interventions

Pentoxifylline

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sharan Sidhu, MBChB

  Quotient Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 11, 2019
• Study Start: February 26, 2018
• Primary Completion: June 4, 2018
• Study Completion: June 4, 2018
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)