- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00995605
AMAP102 - Safety, Tolerability and Pharmacokinetics in Healthy Subjects
14 oktober 2009 uppdaterad av: AnaMar AB
AMAP102 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Oral Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Subjects
The purpose of this study is to determine whether AMAP102 is safe and well tolerated by humans.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
40
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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Leeds, Storbritannien, LS2 9LH
- Covance Clinical Research Unit Ltd.
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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 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- In Groups A, B, D, E and F, subjects will be males of any ethnic origin between 18 and 65 years of with a BMI between 20.0 and 30.0 kg/m2
- In Group C, subjects will be females (of non-childbearing potential) of any ethnic origin between 18 and 65 years with a BMI between 20.0 and 28.0 kg/m2
- For Group C, women will be of non-childbearing potential, defined as surgically sterile or post-menopausal, non-lactating and having a negative serum pregnancy test
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions
Exclusion Criteria:
- Male subjects who are not willing to use appropriate contraception from the time of the first dose until 3 months after the final dosing occasion
- Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
- Subjects who have used any non-prescribed systemic or topical medication within 7 days of the first dose administration
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
- Subjects who are still participating in a clinical study or who have participated in a clinical study involving administration of an investigational drug in the past 3 months
- Subjects who have donated any blood, plasma or platelets in the month prior to screening or who have made donations on more than two occasions within the 12 months preceding the first dose administration
- Subjects with a significant history of drug allergy as determined by the Investigator
- Subjects who have any clinically significant allergic disease as determined by the Investigator
- Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively
- Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits)
- Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day
- Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator
- Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator
- Subjects who are known to have serum hepatitis, or who are carriers of the HBsAg or hepatitis C antibody, or who have a positive result to the test for HIV antibodies
- Subjects who have an abnormality in the 12-lead ECG such that, in the opinion of the investigator, increases the risk of participating in the study, such as QTc(b) interval greater than 430 msec (male) or greater than 450 msec (female), 2nd or 3rd degree Atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR shorter than 110 msec, confirmed by a repeat ECG
- Subjects with a significant cardiac history (e.g. heart failure, hypokalemia, long QT syndrome), significant history of fainting, syncope or family history of sudden cardiac death
- Subjects who, in the opinion of the Investigator, should not participate in the study
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: Enskild gruppuppgift
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Groups SAD
AMAP102 or Placebo as single ascending doses in five groups
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AMAP102 or Placebo
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Experimentell: Groups MAD
AMAP102 or Placebo as multiple ascending doses twice daily for seven days in two groups
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AMAP102 or Placebo
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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Safety and tolerability determined by adverse events, vital signs, ECG and clinical laboratory evaluations
Tidsram: During residential period and at follow up visit
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During residential period and at follow up visit
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Sekundära resultatmått
Resultatmått |
Tidsram |
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Investigate the pharmacokinetic profile of AMAP102 after one oral dose and after multiple oral doses during twice daily dosing for seven days, and compare the pharmacokinetic profile for men and women
Tidsram: PK sampling at defined timepoints during residential period
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PK sampling at defined timepoints during residential period
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Dr Joseph Chiesa, MD FFPM FICR CSci, Covance
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 april 2009
Primärt slutförande (Faktisk)
1 augusti 2009
Avslutad studie (Faktisk)
1 augusti 2009
Studieregistreringsdatum
Först inskickad
13 oktober 2009
Först inskickad som uppfyllde QC-kriterierna
14 oktober 2009
Första postat (Uppskatta)
15 oktober 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
15 oktober 2009
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 oktober 2009
Senast verifierad
1 oktober 2009
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 102-240-01
- 2008-004940-35
- 2704-026
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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