Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-01-03 @ 10:37 PM
Study NCT ID:
NCT02772627
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202
Sponsor:
Bial - Portela C S.A.
Organization:
Study Overview
Official Title:
A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the tolerability and safety of three multiple dose regimens of nebicapone (BIA 3-202 100 mg, 200 mg, and 300 mg 6 times daily) in healthy volunteers. To characterise the steady-state pharmacokinetic and erythrocyte COMT inhibition profiles of nebicapone in healthy volunteers.
Detailed Description:
Study design and methodology:
This was a single centre, human pharmacology (phase I), double-blind, randomised, placebo-controlled study of three multiple rising doses in three sequential groups of healthy volunteers. Subjects were screened for eligibility within 28 days of admission.
Screening:
Screening consisted of review of medical history, physical examination, neurological examination, vital signs, 12-lead ECG, clinical laboratory safety tests (haematology, coagulation, plasma biochemistry, urinalysis, HBsAg, anti-HCV Ab, anti-HIV-1 and anti-HIV-2 Ab), drugs of abuse and alcohol screen, and written informed consent. A pregnancy test was performed in all female subjects. The investigator was informed of the screening results prior to the subject's admission.
Treatment period:
Eligible subjects were admitted to the UFH for one treatment period on the morning of the day prior to receiving the first dose of trial medication and remained in the UFH until at least 48 hours after receiving their final dose of trial medication (final dose: Day 8; leaving the UFH: Day 10). Then, they were to leave and to return on the Days 15, 22 and 29 for the 168 h, 336 h, and 504 h post final dose blood samples and clinical evaluations. Trial medication was administered at 4-h intervals (Group 1: Nebicapone 100 mg/Placebo, 6 times/day; Group 2: Nebicapone 200 mg/Placebo, 6 times/day; Group 3: Nebicapone 300 mg/Placebo, 6 times/day).
On admission (Day -1), subjects had a physical examination, medical history update, vital signs (blood pressure and heart rate), neurological examination, 12-lead ECG, clinical laboratory tests (haematology, coagulation, plasma biochemistry, urinalysis), pregnancy test, screen for drugs of abuse and alcohol, and 24-h urine collection for the assay of urinary electrolytes and creatinine.
On Day 1, Nebicapone /Placebo started being administered at 4 hourly intervals, until the final dose on Day 8.
The following assessments were performed as described: vital signs (blood pressure and heart rate) at Days 1 to 7 pre and 1 hour post 08, 12, 16, 20 and 24 h doses, and Day 8 pre-dose and 1, 24, 48, 168, 336 hours post final dose, and at Day 29; physical examination: admission, at Day 10 and Day 29; neurological examination at on admission, pre-dose and 2 hours post 08, 12, 16, 20 and 24 h doses on Day 1, 2 hours post 08h00 and 20h00 doses on Days 2 to 7, and 2 hours post 08h00 dose on Day 8; 12-lead ECG at 1 hour post 08h00 dose on Days 1, 2, 3, 5 and 8, and 48 h post final dose, and Day 29; continuous lead-II ECG monitoring at 0-6 hours post first dose on Day 1, and 0-4 hours post 08h00 dose on Day 8; blood samples (7 ml) for the assay of plasma nebicapone and its metabolites, and for the assay of the erythrocyte soluble COMT (S-COMT) activity were taken at Day 1, pre-dose, ½, 1, 1½, 2, 3, 4, 8, 12 and 16 hours post first dose (08h00), at Day 8, pre final dose (08h00), ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 168\*, 336\*, and 504\* hours post final dose (\*only for the assay of plasma nebicapone metabolites), and at Days 2, 3, 4, 5, 6, and 7, pre 08h00 and 20h00 doses; urine and blood collection for urinalysis, coagulation, haematology and plasma biochemistry at admission, and on Days 2, 10 and 29; and 24-h urine collection for the assay of urinary electrolytes and creatinine at admission, and on Days 1 and 9.
Adverse events were monitored throughout.
Follow-up:
The end-of-study assessments took place after the last blood sample (504 h) and included: medical history review, physical examination, vital signs, 12-lead ECG, clinical laboratory safety tests, adverse events; pregnancy test (if female).
This was a single centre, human pharmacology (phase I), double-blind, randomised, placebo-controlled study of three multiple rising doses in three sequential groups of healthy volunteers. Subjects were screened for eligibility within 28 days of admission.
Screening:
Screening consisted of review of medical history, physical examination, neurological examination, vital signs, 12-lead ECG, clinical laboratory safety tests (haematology, coagulation, plasma biochemistry, urinalysis, HBsAg, anti-HCV Ab, anti-HIV-1 and anti-HIV-2 Ab), drugs of abuse and alcohol screen, and written informed consent. A pregnancy test was performed in all female subjects. The investigator was informed of the screening results prior to the subject's admission.
Treatment period:
Eligible subjects were admitted to the UFH for one treatment period on the morning of the day prior to receiving the first dose of trial medication and remained in the UFH until at least 48 hours after receiving their final dose of trial medication (final dose: Day 8; leaving the UFH: Day 10). Then, they were to leave and to return on the Days 15, 22 and 29 for the 168 h, 336 h, and 504 h post final dose blood samples and clinical evaluations. Trial medication was administered at 4-h intervals (Group 1: Nebicapone 100 mg/Placebo, 6 times/day; Group 2: Nebicapone 200 mg/Placebo, 6 times/day; Group 3: Nebicapone 300 mg/Placebo, 6 times/day).
On admission (Day -1), subjects had a physical examination, medical history update, vital signs (blood pressure and heart rate), neurological examination, 12-lead ECG, clinical laboratory tests (haematology, coagulation, plasma biochemistry, urinalysis), pregnancy test, screen for drugs of abuse and alcohol, and 24-h urine collection for the assay of urinary electrolytes and creatinine.
On Day 1, Nebicapone /Placebo started being administered at 4 hourly intervals, until the final dose on Day 8.
The following assessments were performed as described: vital signs (blood pressure and heart rate) at Days 1 to 7 pre and 1 hour post 08, 12, 16, 20 and 24 h doses, and Day 8 pre-dose and 1, 24, 48, 168, 336 hours post final dose, and at Day 29; physical examination: admission, at Day 10 and Day 29; neurological examination at on admission, pre-dose and 2 hours post 08, 12, 16, 20 and 24 h doses on Day 1, 2 hours post 08h00 and 20h00 doses on Days 2 to 7, and 2 hours post 08h00 dose on Day 8; 12-lead ECG at 1 hour post 08h00 dose on Days 1, 2, 3, 5 and 8, and 48 h post final dose, and Day 29; continuous lead-II ECG monitoring at 0-6 hours post first dose on Day 1, and 0-4 hours post 08h00 dose on Day 8; blood samples (7 ml) for the assay of plasma nebicapone and its metabolites, and for the assay of the erythrocyte soluble COMT (S-COMT) activity were taken at Day 1, pre-dose, ½, 1, 1½, 2, 3, 4, 8, 12 and 16 hours post first dose (08h00), at Day 8, pre final dose (08h00), ½, 1, 1½, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 168\*, 336\*, and 504\* hours post final dose (\*only for the assay of plasma nebicapone metabolites), and at Days 2, 3, 4, 5, 6, and 7, pre 08h00 and 20h00 doses; urine and blood collection for urinalysis, coagulation, haematology and plasma biochemistry at admission, and on Days 2, 10 and 29; and 24-h urine collection for the assay of urinary electrolytes and creatinine at admission, and on Days 1 and 9.
Adverse events were monitored throughout.
Follow-up:
The end-of-study assessments took place after the last blood sample (504 h) and included: medical history review, physical examination, vital signs, 12-lead ECG, clinical laboratory safety tests, adverse events; pregnancy test (if female).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: