Parkinson DiseasePhase 1NCT01520987

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

A Phase 1 study testing BIA 9-1067 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To assess the pharmacokinetics of BIA 9-1067 in healthy Japanese subjects Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: BIA 9-1067
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 1 siteUnited States
Study dates: May 2011to Nov 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:
First generation Japanese are subjects who may be living outside Japan but were born in Japan to parents of Japanese descent.
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;

Show all 13Show fewer

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.

Who cannot join

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;

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance Clinical Research Unit, Inc.
Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects

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

Conditions: Parkinson Disease
Being tested: BIA 9-1067, Placebo
Keywords: Parkinson Disease, BIA 9-1067
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01520987
Study group	Role	What they receive
Caucasian 5 mg OPC	Experimental	OPC, opicapone, BIA 9-1067 Receives: Drug: BIA 9-1067
Caucasian 25 mg OPC	Experimental	OPC, opicapone, BIA 9-1067 Receives: Drug: BIA 9-1067
Caucasian 50 mg OPC	Experimental	OPC, opicapone, BIA 9-1067 Receives: Drug: BIA 9-1067
Caucasian Placebo	Placebo comparator	Placebo, PLC Receives: Drug: Placebo
Japanese 5 mg OPC	Experimental	OPC, opicapone, BIA 9-1067 Receives: Drug: BIA 9-1067
Japanese 25 mg OPC	Experimental	OPC, opicapone, BIA 9-1067 Receives: Drug: BIA 9-1067
Japanese 50 mg OPC	Experimental	OPC, opicapone, BIA 9-1067 Receives: Drug: BIA 9-1067
Japanese Placebo	Placebo comparator	Placebo, PLC Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1
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
Measured: 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 (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.
Measured: 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 (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
Measured: Day 10
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
Measured: Day 1
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
Measured: Day 10
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
Measured: Day 1
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
Measured: Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Nov 2012

First posted30 Jan 2012 (estimated)
Study startMay 2011
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01520987
Sponsor's protocol ID: BIA-91067-126
Status last verified: May 2016
First submitted: 26 Jan 2012
Last updated: 20 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects
ClinicalTrials.gov ID: NCT01520987
Acronym / sponsor ID: BIA-91067-126
Conditions: Parkinson Disease
Keywords: Parkinson Disease, BIA 9-1067
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: Bial - Portela C S.A.Industry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 30 Jan 2012 (estimated)
Results: Posted 20 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Caucasian 5 mg OPC	Experimental	Drug: BIA 9-1067OPC, opicapone, BIA 9-1067
Caucasian 25 mg OPC	Experimental	Drug: BIA 9-1067OPC, opicapone, BIA 9-1067
Caucasian 50 mg OPC	Experimental	Drug: BIA 9-1067OPC, opicapone, BIA 9-1067
Caucasian Placebo	Placebo comparator	Drug: PlaceboPlacebo, PLC
Japanese 5 mg OPC	Experimental	Drug: BIA 9-1067OPC, opicapone, BIA 9-1067
Japanese 25 mg OPC	Experimental	Drug: BIA 9-1067OPC, opicapone, BIA 9-1067
Japanese 50 mg OPC	Experimental	Drug: BIA 9-1067OPC, opicapone, BIA 9-1067
Japanese Placebo	Placebo comparator	Drug: PlaceboPlacebo, PLC

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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:
Aged 18 to 65 years;
Body weight ≥50 kg;
Within BMI range 18.5 to 30 kg/m2, inclusive;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIA 9-10675 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).	Drug	Caucasian 25 mg OPC, Caucasian 5 mg OPC, Caucasian 50 mg OPC, Japanese 25 mg OPC, Japanese 5 mg OPC, Japanese 50 mg OPC
Placeboonce-daily	Drug	Caucasian Placebo, Japanese Placebo

Primary outcome

Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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

Results and safety

Results posted to the registry on 20 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caucasian 5 mg OPC	13	12
Caucasian 25 mg OPC	12	12
Caucasian 50 mg OPC	11	11
Caucasian Placebo	15	15
Japanese 5 mg OPC	14	14
Japanese 25 mg OPC	14	13
Japanese 50 mg OPC	12	12
Japanese Placebo	14	14

Primary outcome: Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)

Time frame: Day 1. Mean (Standard Deviation). Unit: ng/mL

Measure	Caucasian 5 mg OPC n = 13	Caucasian 25 mg OPC n = 11	Caucasian 50 mg OPC n = 11	Japanese 5 mg OPC n = 14	Japanese 25 mg OPC n = 14	Japanese 50 mg OPC n = 12
Value	182 (64.5)	794 (392)	1540 (493)	176 (93.6)	797 (323)	1736 (381)

Primary outcome: Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)

Time frame: Day 10. Mean (Standard Deviation). Unit: ng/mL

Measure	Caucasian 5 mg OPC n = 13	Caucasian 25 mg OPC n = 12	Caucasian 50 mg OPC n = 11	Japanese 5 mg OPC n = 14	Japanese 25 mg OPC n = 13	Japanese 50 mg OPC n = 12
Value	226 (110)	774 (361)	1550 (655)	276 (130)	959 (273)	1785 (431)

Primary outcome: 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)

Time frame: Day 1. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Caucasian 5 mg OPC n = 13	Caucasian 25 mg OPC n = 11	Caucasian 50 mg OPC n = 11	Japanese 5 mg OPC n = 14	Japanese 25 mg OPC n = 14	Japanese 50 mg OPC n = 12
Value	267 (113)	2013 (800)	3727 (1726)	319 (154)	1886 (692)	4438 (1151)

Primary outcome: 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)

Time frame: Day 10. Mean (Standard Deviation). Unit: ng.h/mL

Measure	Caucasian 5 mg OPC n = 13	Caucasian 25 mg OPC n = 12	Caucasian 50 mg OPC n = 11	Japanese 5 mg OPC n = 14	Japanese 25 mg OPC n = 13	Japanese 50 mg OPC n = 12
Value	349 (169)	2024 (820)	3999 (1770)	441 (139)	2222 (407)	4464 (932)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caucasian 5 mg OPC	0 of 13 (0%)	7 of 13 (53.8%)	Not reported
Caucasian 25 mg OPC	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Caucasian 50 mg OPC	0 of 11 (0%)	6 of 11 (54.5%)	Not reported
Caucasian Placebo	0 of 15 (0%)	8 of 15 (53.3%)	Not reported
Japanese 5 mg OPC	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
Japanese 25 mg OPC	0 of 14 (0%)	6 of 14 (42.9%)	Not reported
Japanese 50 mg OPC	0 of 12 (0%)	6 of 12 (50%)	Not reported
Japanese Placebo	0 of 14 (0%)	5 of 14 (35.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson Disease

Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Haejung Marr, MD principal investigator

Covance

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BIA 9-1067 in people with Parkinson Disease, run by Bial - Portela C S.A. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1) (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01520987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2016.