Healthy
Conditions
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.
Sponsors
Quotient Sciences
Processa Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed