A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093
19 juli 2016 uppdaterad av: Bial - Portela C S.A.
A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093 When Given to Healthy Male Adult Volunteers.
The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects.
Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093.
No subject was a member of more than one treatment group.
Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order.
Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.
Studietyp
Interventionell
Inskrivning (Faktisk)
64
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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London, Storbritannien, SE1 1YR
- Guy's Drug Research Unit
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 35 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Beskrivning
Inclusion Criteria:
Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m2.
- Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
- Subjects who had clinical laboratory tests acceptable to the investigator.
- Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
- Subjects who were non-smokers or who smoked less than 10 cigarettes (or equivalent) per day.
- Subjects who were able and willing to give written informed consent.
Exclusion Criteria:
- Subjects who did not conform to the above inclusion criteria.
- Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- Subjects who had a clinically relevant surgical history.
- Subjects who had a clinically relevant family history.
- Subjects who had a history of relevant atopy.
- Subjects who had a history of relevant drug hypersensitivity (carbamazepine and related compounds)
- Subjects who had a history of alcoholism.
- Subjects who had a history of drug abuse.
- Subjects who consumed more than 28 units of alcohol a week.
- Subjects who had a significant infection or known inflammatory process on screening and/or admission
- Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- Subjects who had an acute infection such as influenza at the time of screening and/or admission.
- Subjects who had used prescription drugs within 4 weeks of dosing.
- Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of dosing.
- Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.
- Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.
- Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
- Subjects who could not communicate reliably with the investigator.
- Subjects who were unlikely to co-operate with the requirements of the study.
- Subjects who were unwilling or unable to give written informed consent.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Group 1 (20 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 2 (50 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 3 (100 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 4 (200 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 5 (400 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 6 (600 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 7 (900 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
|
Experimentell: Group 8 (1200 mg)
|
BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
Andra namn:
Identical placebo administered as oral tablets with 200 ml potable water.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total Number of Adverse Events
Tidsram: up to 20 weeks
|
An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
|
up to 20 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2000
Primärt slutförande (Faktisk)
1 oktober 2000
Avslutad studie (Faktisk)
1 oktober 2000
Studieregistreringsdatum
Först inskickad
20 juni 2014
Först inskickad som uppfyllde QC-kriterierna
20 juni 2014
Första postat (Uppskatta)
24 juni 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
20 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BIA-2093-101
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