Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
20. juli 2016 oppdatert av: Bial - Portela C S.A.
A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers
The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of BIA 5-453 in six groups of healthy male subjects.
In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data (including plasma exploratory pharmacokinetics) prior to proceeding to a higher dose level.
Studietype
Intervensjonell
Registrering (Faktiske)
57
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
Inclusion Criteria:
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must have been able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Exclusion Criteria:
Medical History
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study Day1.
- History of drug abuse within 1 year before study Day1.
- History of alcoholism within 1 year before Day1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
History of any clinically important drug allergy.
Physical and Laboratory Findings
- An automatic ECG QTc interval reading at screening or enrolment >450 ms.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
Prohibited treatments
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 72 before study day -1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
- Donation of blood (ie 450 ml) within 90 days before study Day1.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BIA 5-453 25 mg or placebo
Multiple oral doses of BIA 5-453 25 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
Andre navn:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
Eksperimentell: BIA 5-453 50 mg or placebo
Multiple oral doses of BIA 5-453 50 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
Andre navn:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
Eksperimentell: BIA 5-453 100 mg or placebo
Multiple oral doses of BIA 5-453 100 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
Andre navn:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
Eksperimentell: BIA 5-453 200 mg or placebo
Multiple oral doses of BIA 5-453 200 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
Andre navn:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
Eksperimentell: BIA 5-453 400 mg or placebo
Multiple oral doses of BIA 5-453 400 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
Andre navn:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
|
Eksperimentell: BIA 5-453 600 mg or placebo
Multiple oral doses of BIA 5-453 600 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
|
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
Andre navn:
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percent of subjects with at least one adverse event
Tidsramme: through study completion, an average of 10 days
|
through study completion, an average of 10 days
|
|
|
Percent of subjects by dose group with at least one treatment-emergent adverse event (TEAEs)
Tidsramme: through study completion, an average of 10 days
|
Treatment-emergent adverse events are adverse events that occurred either in the 72 hours after dosing or that was present prior to dosing but exacerbated within 72 hours after dosing.
|
through study completion, an average of 10 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2007
Primær fullføring (Faktiske)
1. juli 2008
Studiet fullført (Faktiske)
1. juli 2008
Datoer for studieregistrering
Først innsendt
19. juli 2016
Først innsendt som oppfylte QC-kriteriene
20. juli 2016
Først lagt ut (Anslag)
21. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. juli 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2016
Sist bekreftet
1. juli 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BIA-5453-102
- 2007-004142-33 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .