- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02101190
Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment
Open-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment
Studieöversikt
Detaljerad beskrivning
This was an open-label, single-dose, parallel-group, in-patient, nonrandomized study conducted in 8 patients with moderate chronic hepatic impairment and in 8 healthy matched subjects matched by origin, age, sex, weight, and smoking habits.
Each hepatic impaired patient and matched healthy subject participated in the study for approximately one month, including a 21-day screening period and a 4-day/4-night inpatient period. The inpatient period covered the period from Day -1 to Day 4 morning (through 72 hours after administration). The final study evaluation was performed for all subjects in the morning of the day of discharge, Day 4.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
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Rennes, Frankrike, F-35000
- Biotrial, 7-9 rue Jean-Louis Bertrand
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Moscow, Ryska Federationen, 17292
- City clinical Hospital N°64
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Moscow, Ryska Federationen
- City clinical Hospital N°3
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
All subjects:
- Men or non-lactating and non-pregnant women,
- Women of non-childbearing potential (WONCBP), expected to be surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or postmenopausal for >1 year,
- Women of childbearing potential (WOCBP), expected to be using an acceptable method of contraception (sexual abstinence, implants, IUD, injectables, vasectomised partner or association of condom + spermicide, diaphragm + spermicide, diaphragm + condom) for a period of at least 1 month before and after dose administration. WOCBP were expected to have a negative pregnancy test (serum beta-human chorionic gonadotropin [β-HCG]) result within 48 hours before the start of the first IMP administration. Hormonal contraceptives were not allowed because the effect of BIA 9-1067 on the metabolism of oral contraceptives and vice versa is not yet known,
- Male subjects should not have been planning to father a child or donate sperm, during the study and 1 month after the end of the study. Acceptable methods of contraception comprised condom and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for the last 2 months),
- Expected to have a high probability for compliance with and completion of the study, Hepatic Impaired Patients only:
- Aged 18 to 65 years,
- Body weight ≥ 50 kg,
- Child Pugh class B (score at 7, 8 or 9) calculated according to the Child-Pugh classification based on history, physical examination, and laboratory test results at screening and on Day -1,
- Hepatic impairment should not have been associated to an underlying systemic disease,
Medications necessary for the management of the hepatic disease or concomitant conditions were permitted if the therapeutic regimen has been stable for at least 7 days before BIA 9-1067 administration and if they did not interfere with the kinetics of the tested product,
Matched Healthy Subjects only:
- Aged 18 to 65 years,
- Body weight ≥ 50 kg,
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT) and creatinine levels should have been strictly within the normal range for eligibility.
Exclusion Criteria:
- Presence or history of any disorder that may prevent the successful completion of the study. Allergies and Adverse Drug Reactions
- 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 (e.g tolcapone or entacapone).
- Positive pregnancy test result (serum Beta-HCG) for women of childbearing potential 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 the end of the inpatient confinement period.
- 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.
- Evidence of unstable clinically significant disease other than impaired hepatic function (e.g., cardiovascular, cerebrovascular, respiratory, renal disease, or any serious disorder that currently requires a physician's care).
- Recent history or presence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of BIA 9-1067 (except hepatic impairment).
- Patients with severe encephalopathy.
- Acute exacerbation of hepatic disease, as indicated by worsening of clinical and/or laboratory signs of hepatic impairment, within the 2 weeks before BIA 9-1067 administration (eg, advanced ascites, infection of ascites, fever, hepatic encephalopathy or active gastrointestinal bleeding (hematemesis, melena), significant abdominal pain, persistent nausea and vomiting, or a worsening of total bilirubin or prothrombin time by >50%).
- Presence of a hepatocellular carcinoma, or an acute hepatic disease caused by infection or drug toxicity.
- Presence of surgically created portal-systemic shunt.
- Positive serologic finding for human immunodeficiency virus (HIV) antibodies.
Prescription and over-the-counter (OTC) medication doses must be stable for 7 days before IMP administration.
Healthy Matched Subjects only:
- 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.
- Any clinically important deviation from normal limits in physical examination, vital signs, or 12-lead ECGs.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhea) within 7 days of study day 1.
- Positive serologic findings for HIV antibodies, hepatitis B surface antigen (Hbs Ag), and/or hepatitis C virus (HCV) antibodies.
- Recent history or presence of any disorder that may interfere with the absorption, distribution, metabolism, or excretion of BIA 9-1067.
- Use of any prescription drug within 30 days of IMP administration.
- Use of any OTC drugs including herbal supplements (except for the occasional use of acetaminophen and vitamins ≤100% recommended daily allowance) within 14 days of study day 1.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Group 1 - Hepatic impaired subjects
Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067
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Opicapone, OPC
Andra namn:
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Experimentell: Group 2 - Healthy subjects
Group 2 - healthy subjects treated with BIA 9-1067
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Opicapone, OPC
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Cmax - Maximum Plasma Concentration of BIA 9-1067
Tidsram: pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
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BIA 9-1067 Cmax following a single dose of 50mg BIA 9-1067
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pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
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Tmax - Time to Reach Cmax
Tidsram: pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
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BIA 9-1067 Tmax following a single dose of 50mg BIA 9-1067
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pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
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Area Under the Curve (AUC0-t)
Tidsram: pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
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BIA 9-1067 AUC0-t following a single dose of 50mg BIA 9-1067
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pre-dose (within 1 hour before dose administration) and then at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 hours post-dose
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Patricio Soares-da-Silva, MD, PhD, Bial - Portela & Cª, S.A.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Parkinsons sjukdom
- Basala ganglia sjukdomar
- Rörelsestörningar
- Synukleinopatier
- Neurodegenerativa sjukdomar
- Parkinsons sjukdom
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antiparkinsonmedel
- Medel mot dyskinesi
- Katekol O-metyltransferashämmare
- Opicapone
Andra studie-ID-nummer
- BIA-91067-106
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