Status:
COMPLETED
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
Lead Sponsor:
Processa Pharmaceuticals
Collaborating Sponsors:
Quotient Sciences
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 provi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2018
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03836222
Start Date
February 26 2018
End Date
June 4 2018
Last Update
February 12 2019
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom