Parkinson Disease
Conditions
Keywords
Parkinson Disease, BIA 9-1067
Brief summary
To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects
Detailed description
Randomized, double-blind, placebo-controlled, multiple ascending dose, parallel-group, pharmacokinetic (PK) and pharmacodynamic (PD) study
Interventions
DRUGBIA 9-1067
5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
DRUGPlacebo
once-daily
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Men or nonlactating and nonpregnant women; * Caucasian or Japanese subjects. Caucasian subjects are subjects of European descent; Japanese subjects must be first or second generation. Generations will be defined as follows: 1. First generation Japanese are subjects who may be living outside Japan but were born in Japan to parents of Japanese descent. 2. Second generation Japanese are subjects who were born outside of Japan to first generation Japanese parents. * Aged 18 to 65 years; * Body weight ≥50 kg; * Within BMI range 18.5 to 30 kg/m2, inclusive; * Healthy, as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG. Creatinine and ALT levels must be strictly within the normal range for eligibility at Check-in; * Women of nonchildbearing potential must be surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or postmenopausal for ≥1 year; * Women of childbearing potential must be using an effective nonhormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject) for a period of at least 1 month before and after dose administration. Women of childbearing potential must have a negative pregnancy test result within 48 hours before the start of the first investigational medicinal product (IMP) administration. Hormonal contraceptives will not be allowed because the effect of BIA 9 1067 on the metabolism of hormonal contraceptives and vice versa is not yet known; * Nonsmokers, defined as having smoked ≤10 cigarettes per week for the 3 months prior to dosing, abstained from smoking for 7 days prior to Check-in, and having a negative cotinine level ≤500 ng/mL at Check-in; * Have a high probability for compliance with and completion of the study, in the opinion of the Investigator; * Able to comprehend and willing to sign an ICF.
Exclusion criteria
* Presence or history of any disorder that may prevent the successful completion of the study; * History of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions; * Known or suspected allergy or other adverse drug reactions to the trial product or related products (eg, tolcapone or entacapone); * History of alcoholism or excessive daily alcohol consumption within the past year. Excessive alcohol consumption is regarded as an average weekly intake of more than 14 units for women and 21 units for men (1 unit of alcohol = 8 to 10 g and is approximately equivalent to 1 glass of wine or 250 mL of beer or a standard measure of spirits); * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as judged by the Investigator or Sponsor's Medical Monitor; * Any clinically important deviation from normal limits in physical examination, vital signs, or 12-lead ECGs, as judged by the Investigator or Sponsor's Medical Monitor; * Acute disease state (eg, nausea, vomiting, fever, diarrhea) within 7 days of Study Day 1; * Positive serologic findings for HIV antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus antibodies (anti-HCV); * Positive screen for drugs of abuse and alcohol; * Recent history or presence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of BIA 9 1067; * Positive pregnancy test result for WOCBP only; * Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola), grapefruit, grapefruit-containing products, or alcoholic beverages from 48 hours before Study Day 1 until Discharge (Day 16); * Involvement in other investigational studies of any type within 30 days of BIA 9-1067 administration; * Donation of blood within 90 days of Study Day 1; * Use of any prescription drug within 30 days of IMP administration unless deemed acceptable by the Principal Investigator (PI) and Medical Monitor; * Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen and vitamins ≤100% recommended daily allowance) within 14 days of Study Day 1 unless deemed acceptable by the PI and Medical Monitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | Day 1 | Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. |
| Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | Day 10 | Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
| AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | Day 1 | AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose. |
| AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | Day 10 | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
| AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | Day 1 | AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose |
| AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | Day 10 | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
| Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | Day 1 | Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose |
| Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | Day 10 | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caucasian 5 mg OPC OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 13 |
| Caucasian 25 mg OPC OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 12 |
| Caucasian 50 mg OPC OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 11 |
| Caucasian Placebo Placebo, PLC
Placebo: once-daily | 15 |
| Japanese 5 mg OPC OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 14 |
| Japanese 25 mg OPC OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 14 |
| Japanese 50 mg OPC OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily). | 12 |
| Japanese Placebo Placebo, PLC
Placebo: once-daily | 14 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Caucasian Placebo | Caucasian 5 mg OPC | Caucasian 25 mg OPC | Caucasian 50 mg OPC | Japanese 5 mg OPC | Japanese 25 mg OPC | Japanese 50 mg OPC | Japanese Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 13 Participants | 12 Participants | 11 Participants | 14 Participants | 14 Participants | 12 Participants | 14 Participants | 105 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 7 Participants | 6 Participants | 7 Participants | 10 Participants | 6 Participants | 8 Participants | 60 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 7 Participants | 4 Participants | 6 Participants | 6 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 13 | 5 / 12 | 6 / 11 | 8 / 15 | 3 / 14 | 6 / 14 | 6 / 12 | 5 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 | 0 / 11 | 0 / 15 | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 14 |
Outcome results
Primary
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)
AUC0-∞ - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caucasian 5 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | 338 ng.h/mL | Standard Deviation 48.6 |
| Caucasian 25 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | 2039 ng.h/mL | Standard Deviation 798 |
| Caucasian 50 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | 3756 ng.h/mL | Standard Deviation 1734 |
| Japanese 5 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | 357 ng.h/mL | Standard Deviation 163 |
| Japanese 25 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | 1976 ng.h/mL | Standard Deviation 673 |
| Japanese 50 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1) | 4470 ng.h/mL | Standard Deviation 1147 |
Primary
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Time frame: Day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caucasian 5 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | 409 ng.h/mL | Standard Deviation 147 |
| Caucasian 25 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | 2056 ng.h/mL | Standard Deviation 817 |
| Caucasian 50 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | 4028 ng.h/mL | Standard Deviation 1786 |
| Japanese 5 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | 465 ng.h/mL | Standard Deviation 145 |
| Japanese 25 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | 2240 ng.h/mL | Standard Deviation 406 |
| Japanese 50 mg OPC | AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10) | 4510 ng.h/mL | Standard Deviation 938 |
Primary
AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)
AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caucasian 5 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | 267 ng.h/mL | Standard Deviation 113 |
| Caucasian 25 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | 2013 ng.h/mL | Standard Deviation 800 |
| Caucasian 50 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | 3727 ng.h/mL | Standard Deviation 1726 |
| Japanese 5 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | 319 ng.h/mL | Standard Deviation 154 |
| Japanese 25 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | 1886 ng.h/mL | Standard Deviation 692 |
| Japanese 50 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1) | 4438 ng.h/mL | Standard Deviation 1151 |
Primary
AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)
AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Time frame: Day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caucasian 5 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | 349 ng.h/mL | Standard Deviation 169 |
| Caucasian 25 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | 2024 ng.h/mL | Standard Deviation 820 |
| Caucasian 50 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | 3999 ng.h/mL | Standard Deviation 1770 |
| Japanese 5 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | 441 ng.h/mL | Standard Deviation 139 |
| Japanese 25 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | 2222 ng.h/mL | Standard Deviation 407 |
| Japanese 50 mg OPC | AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10) | 4464 ng.h/mL | Standard Deviation 932 |
Primary
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caucasian 5 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 182 ng/mL | Standard Deviation 64.5 |
| Caucasian 25 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 794 ng/mL | Standard Deviation 392 |
| Caucasian 50 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 1540 ng/mL | Standard Deviation 493 |
| Japanese 5 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 176 ng/mL | Standard Deviation 93.6 |
| Japanese 25 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 797 ng/mL | Standard Deviation 323 |
| Japanese 50 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 1736 ng/mL | Standard Deviation 381 |
Primary
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Time frame: Day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caucasian 5 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 226 ng/mL | Standard Deviation 110 |
| Caucasian 25 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 774 ng/mL | Standard Deviation 361 |
| Caucasian 50 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 1550 ng/mL | Standard Deviation 655 |
| Japanese 5 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 276 ng/mL | Standard Deviation 130 |
| Japanese 25 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 959 ng/mL | Standard Deviation 273 |
| Japanese 50 mg OPC | Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 1785 ng/mL | Standard Deviation 431 |
Primary
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Caucasian 5 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 2.0 hours |
| Caucasian 25 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 2.0 hours |
| Caucasian 50 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 3.0 hours |
| Japanese 5 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 2.0 hours |
| Japanese 25 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 2.0 hours |
| Japanese 50 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) | 2.0 hours |
Primary
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Time frame: Day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Caucasian 5 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 1.00 hours |
| Caucasian 25 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 2.00 hours |
| Caucasian 50 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 1.50 hours |
| Japanese 5 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 2.00 hours |
| Japanese 25 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 2.00 hours |
| Japanese 50 mg OPC | Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10) | 2.00 hours |