Clinical trial NCT01520987: Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson Disease
BIA 9-1067
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
timeFrame: Day 1
measure: Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
timeFrame: Day 10
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 10
measure: AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)
timeFrame: Day 1
measure: AUC0-∞ - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)
timeFrame: Day 10
measure: Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
timeFrame: Day 1
measure: Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
timeFrame: Day 10
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Hawaii
Study officials:
affiliation: Covance
name: Haejung Marr, MD
role: PRINCIPAL_INVESTIGATOR
References: