A Phase 1 interventional study of PBF-677 and Placebo in Glaucoma, sponsored by Palobiofarma SL. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-17.
Sponsored by Palobiofarma SL · Phase 1, Interventional, and Treatment
The proposed trial a "Randomized, Double Blind, Placebo Controlled "first in-human" Study to Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-677 in Male Healthy Volunteers" (Protocol Code No:CUNFI-1509 EudraCT No:2015-003546-57) will be a single-centre, randomized, double-blind, dose escalation study without therapeutic benefit, in which PBF-677 will be administered as single, oral, ascending-dose to volunteers.
Up to four different rising doses (100 mg, 200 mg, 400 mg and 600 mg) will be tested in groups of 8 participants; in each dose level participants will be randomized to active drug or placebo in a 6:2 fashion. As this will be the first time that PBF-677 in going to be administered to humans, as a safety measure a stepwise drug administration will be performed in each cohort. The volunteers of each cohort will be divided in 3 blocks/subgroups: Initially, one volunteer will receive active drug (subgroup 1). After 48h of safety and tolerability assessment, a second subgroup of 3 volunteers will receive 2 active drug and 1 placebo and after further 48h of safety and tolerability assessments a third subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety, parameters of corresponding dose level the process will replicate one week afterwards in the following dosages.
The principal variable safety and tolerability of PBF-677 will be evaluated with physical records (Electrocardiogram (ECG), vital signs, blood chemistry and haematology, conducted before, during and after study course). Assessment of the pharmacokinetic profile (Maximum plasma concentration of the drug (peak) after single dose (Cmax),Time necessary to reach Cmax (tmax), Area under the time-concentration curve to "zero" to time "t" (AUC0t), and Elimination half-life (t1/2) of PBF-677 will be included as secondary variable.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 32 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Drug: PBF-677
Drug: PBF-677
Drug: PBF-677
Drug: PBF-677
Drug: Placebo
Drug: Placebo
Drug: Placebo
Drug: Placebo
once daily oral administration
once daily oral administration
Number of Adverse events
The occurrence of adverse events will be monitored through the complete study. Adverse events will be recorded with the following information: severity grade (mild, moderate, severe); suspected/unsuspected relationship to the study drug; duration (date and time of onset, defined as precisely as possible, and end date or if continuing at final exam)
Time frame: 1 week
Number of Participants With Abnormal Laboratory Values
The following laboratory evaluations will be performed at the study site: * Hematology - Hemoglobin, Hematocrit, White Blood Cells (WBC) with differential, Red Blood Cells (RBC) count, Platelet count. * Biochemistry - Sodium, Potassium, Calcium, Inorganic Phosphorus, Total Proteins, Total Bilirubin, Albumin, Fasting Cholesterol, Fasting Triglycerides, Serum Creatinine, Creatine Kinase (CK), Fasting Glucose, Aspartate amino transferase (AST), Alanine amino transferase (ALT), Glutamyl transpeptidase (GGT), Alkaline Phosphatase, BUN (urea-N), Uric Acid. * Urinalysis - Glucose, Leukocytes, Ketonic Bodies, Nitrites, Proteins, Bilirubin, Urobilinogen and Erythrocytes. A midstream urine sample will be obtained, in order to avoid contamination and allow a proper assessment.
Time frame: 5-7 days post administration
Electrocardiogram (EKG)
Time frame: [pre-dose], [+ 40min], [+ 1.5h], [+ 3h], [+ 24h] and Days (5-7) post-medication
Vital signs
This evaluation will include automated/manual assessments of systolic and diastolic blood pressure, heart and respiratory rate.
Time frame: [pre-dose], [+ 20 min], [+ 60min], [+ 2h], [+ 4h], [+ 8h], [+ 12h] , [+ 24h] and Days (5-7) post-medication
Physical examination
This evaluation will include an examination of general appearance, eyes, throat-nose-ears, teeth, skin, lung, heart, abdomen general, liver, spleen, kidneys, spine, lymph nodes, extremities, short neurological status. Genital, urinary tract and rectal examination will not be done on a routine basis.
Time frame: At day-1 (predose), at + 24h post-drug administration and at the follow-up (5-7) days
Maximum plasma concentration of PBF-677 (peak) after single dose (Cmax)
The Blood extractions will be done at the following time points: Baseline \[pre-dose\], \[+ 10 min\], \[+ 20 min\], \[+ 40 min\], \[+ 60 min\], \[+ 1.5h\], \[+ 2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+ 8h\], \[+ 12h\], \[+16h\] and \[+ 24h\] post-medication. Plasma concentrations of parent compound (PBF-677) will be measured with a previously validated method. The Pharmacokinetic (PK) parameter will be derived from each individual plasma concentration versus time profile using standard methods.
Time frame: 0-24 h post dose
Time necessary to reach Maximum plasma concentration of PBF-677 (Tmax)
The Blood extractions will be done at the following time points: Baseline \[pre-dose\], \[+ 10 min\], \[+ 20 min\], \[+ 40 min\], \[+ 60 min\], \[+ 1.5h\], \[+ 2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+ 8h\], \[+ 12h\], \[+16h\] and \[+ 24h\] post-medication. Plasma concentrations of parent compound (PBF-677) will be measured with a previously validated method. The Pharmacokinetic (PK) parameter will be derived from each individual plasma concentration versus time profile using standard methods.
Time frame: 0-24 h post dose
Area under the time-concentration curve to "zero" to time "t" (AUC0t)
The Blood extractions will be done at the following time points: Baseline \[pre-dose\], \[+ 10 min\], \[+ 20 min\], \[+ 40 min\], \[+ 60 min\], \[+ 1.5h\], \[+ 2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+ 8h\], \[+ 12h\], \[+16h\] and \[+ 24h\] post-medication. Plasma concentrations of parent compound (PBF-677) will be measured with a previously validated method. The Pharmacokinetic (PK) parameter will be derived from each individual plasma concentration versus time profile using standard methods.
Time frame: 0-24 h post dose
Elimination half-life (t1/2) of PBF-677
The Blood extractions will be done at the following time points: Baseline \[pre-dose\], \[+ 10 min\], \[+ 20 min\], \[+ 40 min\], \[+ 60 min\], \[+ 1.5h\], \[+ 2 h\], \[+ 2.5 h\], \[+ 3 h\], \[+ 4h\], \[+ 8h\], \[+ 12h\], \[+16h\] and \[+ 24h\] post-medication. Plasma concentrations of parent compound (PBF-677) will be measured with a previously validated method. The Pharmacokinetic (PK) parameter will be derived from each individual plasma concentration versus time profile using standard methods.
Time frame: 0-24 h post dose
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Palobiofarma SL