ClinicalTrials.gg
Sign In
CompletedNCT01520987Updated Jun 20, 2016Results posted

Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects

A Phase 1 interventional study of BIA 9-1067 and Placebo in Parkinson Disease, sponsored by Bial - Portela C S.A.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by Bial - Portela C S.A. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects

Read the detailed description

Randomized, double-blind, placebo-controlled, multiple ascending dose, parallel-group, pharmacokinetic (PK) and pharmacodynamic (PD) study

02

Conditions studied

  • Parkinson Disease

Browse trials for

Keywords

  • Parkinson Disease
  • BIA 9-1067
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 105 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Bial - Portela C S.A. is the lead sponsor of 136 studies on the registry; 1 is open to participants now.

Browse Bial - Portela C S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
105 participants (actual)

Study arms

  • Experimental
    Caucasian 5 mg OPC

    OPC, opicapone, BIA 9-1067

    Drug: BIA 9-1067

  • Experimental
    Caucasian 25 mg OPC

    OPC, opicapone, BIA 9-1067

    Drug: BIA 9-1067

  • Experimental
    Caucasian 50 mg OPC

    OPC, opicapone, BIA 9-1067

    Drug: BIA 9-1067

  • Placebo comparator
    Caucasian Placebo

    Placebo, PLC

    Drug: Placebo

  • Experimental
    Japanese 5 mg OPC

    OPC, opicapone, BIA 9-1067

    Drug: BIA 9-1067

  • Experimental
    Japanese 25 mg OPC

    OPC, opicapone, BIA 9-1067

    Drug: BIA 9-1067

  • Experimental
    Japanese 50 mg OPC

    OPC, opicapone, BIA 9-1067

    Drug: BIA 9-1067

  • Placebo comparator
    Japanese Placebo

    Placebo, PLC

    Drug: Placebo

Interventions

  • DrugBIA 9-1067

    5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).

  • DrugPlacebo

    once-daily

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Results

Posted Jun 20, 2016

Participant flow

Participant flow — Overall Study
MilestoneCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCCaucasian PlaceboJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPCJapanese Placebo
Started1312111514141214
Dosed1312111514141214
Completed1212111514131214
Not completed10000100
Withdrew: Withdrawal by subject10000100

Outcome measures

PrimaryCmax 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
Reported as:
Mean · ng/mL
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
ng/mLCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPC
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)182 ± 64.5794 ± 3921540 ± 493176 ± 93.6797 ± 3231736 ± 381
PrimaryCmax 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
Reported as:
Mean · ng/mL
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
ng/mLCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPC
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)226 ± 110774 ± 3611550 ± 655276 ± 130959 ± 2731785 ± 431
PrimaryAUC0-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
Reported as:
Mean · ng.h/mL
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)
ng.h/mLCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 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)267 ± 1132013 ± 8003727 ± 1726319 ± 1541886 ± 6924438 ± 1151
PrimaryAUC0-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
Reported as:
Mean · ng.h/mL
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)
ng.h/mLCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 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)349 ± 1692024 ± 8203999 ± 1770441 ± 1392222 ± 4074464 ± 932
PrimaryAUC0-∞ - 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
Reported as:
Mean · ng.h/mL
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)
ng.h/mLCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPC
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)338 ± 48.62039 ± 7983756 ± 1734357 ± 1631976 ± 6734470 ± 1147
PrimaryAUC0-∞ - 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
Reported as:
Mean · ng.h/mL
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)
ng.h/mLCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPC
AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)409 ± 1472056 ± 8174028 ± 1786465 ± 1452240 ± 4064510 ± 938
PrimaryTmax 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
Reported as:
Median · hours
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
hoursCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPC
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)2.0 (0.75 to 5.0)2.0 (1.5 to 4.0)3.0 (1.5 to 3.0)2.0 (1.0 to 5.0)2.0 (1.0 to 8.0)2.0 (0.75 to 5.0)
PrimaryTmax 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
Reported as:
Median · hours
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
hoursCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPC
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)1.00 (0.50 to 5.00)2.00 (1.00 to 4.00)1.50 (0.50 to 3.00)2.00 (0.75 to 5.00)2.00 (0.50 to 4.00)2.00 (1.00 to 4.00)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Caucasian 5 mg OPC—0/13 (0%)7/13 (53.8%)
Caucasian 25 mg OPC—0/12 (0%)5/12 (41.7%)
Caucasian 50 mg OPC—0/11 (0%)6/11 (54.5%)
Caucasian Placebo—0/15 (0%)8/15 (53.3%)
Japanese 5 mg OPC—0/14 (0%)3/14 (21.4%)
Japanese 25 mg OPC—0/14 (0%)6/14 (42.9%)
Japanese 50 mg OPC—0/12 (0%)6/12 (50%)
Japanese Placebo—0/14 (0%)5/14 (35.7%)
Most frequent other events
Showing 10 of 41
Most frequent other events
EventCaucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCCaucasian PlaceboJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPCJapanese Placebo
Vessel puncture site haematomaGeneral disorders4/133/120/112/151/142/143/122/14
NauseaGastrointestinal disorders3/130/120/111/150/140/140/121/14
Tension headacheNervous system disorders0/130/120/110/150/140/142/120/14
HeadacheNervous system disorders0/130/121/111/152/141/141/122/14
IrritabilityGeneral disorders0/130/121/110/150/140/140/120/14
Arthropod biteInjury, poisoning and procedural complications0/130/121/111/151/140/140/120/14
Joint injuryInjury, poisoning and procedural complications0/130/121/110/150/140/140/120/14
DyspepsiaGastrointestinal disorders1/130/121/110/150/140/140/120/14
DizzinessNervous system disorders1/130/121/111/150/140/140/121/14
Back painMusculoskeletal and connective tissue disorders0/130/121/110/150/140/141/120/14

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Caucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCCaucasian PlaceboJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPCJapanese PlaceboTotal
<=18 years000000000
Between 18 and 65 years1312111514141214105
>=65 years000000000
Sex: Female, Male
Sex: Female, Male(Participants)Caucasian 5 mg OPCCaucasian 25 mg OPCCaucasian 50 mg OPCCaucasian PlaceboJapanese 5 mg OPCJapanese 25 mg OPCJapanese 50 mg OPCJapanese PlaceboTotal
Female77697106860
Male6556746645
08

Study locations

1 site
  • Covance Clinical Research Unit, Inc.
    Honolulu, Hawaii 96813, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2011, a primary completion of Nov 2012 and a completion of Nov 2012. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2016, 3 years 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2012
First posted
Jan 30, 2012
Start
May 2011
Primary completionActual
Nov 2012
CompletionActual
Nov 2012
Results first posted
Jun 20, 2016
Last update
Jun 20, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01520987
Lead sponsor
Bial - Portela C S.A.
Responsible party
Sponsor
First posted
Jan 30, 2012
Start date
May 2011
Primary completion
Nov 2012
Completion
Nov 2012
Results posted
Jun 20, 2016
Last update
Jun 20, 2016

Study contacts

Haejung Marr, MD
principal investigator · Covance

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Opicapone

Other studies in this condition

Parkinson Disease →

Other studies from this sponsor

Bial - Portela C S.A. →

Start the discussion