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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836222
• Other study ID #: PCS499.1005
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2018
• Est. completion date: June 4, 2018

Study information

• Verified date: February 2019
• Source: Processa Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PCS499
MR tablet
• Trental
comparator tablet

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Ruddington	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Processa Pharmaceuticals	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.