- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02564861
Multiple Dose Study of D1971a in Healthy Volunteers
27 aprile 2017 aggiornato da: Daiichi Sankyo, Inc.
A Phase I, Double-Blind, Randomised, Placebo Controlled, Multiple-Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DS-1971a in Healthy Male and Female Subjects
This is a randomised, double-blind, placebo-controlled multiple dose study designed to explore the safety, tolerability and PK of DS-1971a following oral administration over 14 days to healthy male and female subjects.
Each participant receives lidocaine as a local anaesthetic before inserting the intravenous cannula.
Panoramica dello studio
Descrizione dettagliata
Within strictly defined limits, the protocol permits the dose escalation committee to amend the dose escalation rules, doses proposed in the study protocol and to change the timing of or to add additional assessments following review of the safety, tolerability and plasma DS-1971a concentration data.
The decisions to change the doses will be documented in the minutes of the dose escalation committee.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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London, Regno Unito
- Mammersmith Medicines Research Ltd.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Healthy male and female subjects aged 18 years to 65 years.
- A body mass index (BMI) in the range 18 kg/m2 to 30 kg/m2, inclusive, and weighing between 50 kg and 100 kg, inclusive at screening. BMI is calculated as weight [kg]/(height [m])2.
Female subjects must be of non-childbearing potential as follows:
- Must be postmenopausal (the last menstrual period was at least 12 months before Screening, and a follicle stimulating hormone [FSH] test at Screening confirms postmenopausal status); or
- Must be surgically sterile having undergone hysterectomy, bilateral oophorectomy, bilateral salpingectomy and/or bilateral tubal ligation.
- Willing to comply with all study restrictions, including the use of contraception, concomitant medication, and dietary and lifestyle restrictions.
- Sufficient intelligence to understand the nature of the study and any hazards of participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with requirements of, the entire study.
- Have given written consent to participate in the study after reading the ICF, and after having the opportunity to discuss the study with the Investigator or his delegate.
- Have given written consent to have his/her data entered into The Over volunteering Prevention System.
Exclusion Criteria:
- Clinically relevant abnormal history, physical findings, ECG findings, or laboratory values that could interfere with the objectives of the study or compromise the safety of the subject.
- Presence or history of acute or chronic illness, including (but not limited to) liver or kidney disease, hypertension, seizures, or any known impairment of endocrine, or other specific body-organ dysfunction.
- History of serious reaction to any medicine.
- Presence or history of malignant disease.
- Acute or chronic infectious disease, including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or C virus (HCV) infection.
- Surgery (eg, stomach bypass) or medical condition that might affect how the body handles or absorbs medicines.
- Significant illness within 4 weeks before the first dose of study medication.
- Participation in another clinical study of a new chemical entity or a prescription medicine within the previous 3 months, or unwilling to abstain from participating in other clinical trials during the study and for 3 months after receipt of study medication.
- Blood pressure (BP) and heart rate in semi-supine position at the Screening examination outside the ranges 90 mmHg to 140 mmHg systolic, 40 mmHg to 90 mmHg diastolic; heart rate < 40 beats/min to > 100 beats/min. Subjects with Stage 1 hypertension (systolic 140 mmHg to 160 mmHg; diastolic 90 mmHg to 100 mmHg) may be enrolled provided they do not have evidence of end-organ damage, diabetes or a 10 year cardiovascular risk > 20%.
- Abnormal ECG waveform morphology at Screening that would preclude accurate measurement of the uncorrected QT interval (QT) duration.
- QT interval for heart rate corrected using QTcF interval duration > 430 ms for men or > 450 ms for women, obtained as an average from the measurements on duplicate Screening ECGs over a brief recording period.
- Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73m2 (based on Modification of Diet in Renal Disease [MDRD] equation) or an absolute creatinine value outside the normal range.
- Use of any prescription or over the counter (OTC) medications, or herbal remedies (such as St John's wort), known to be strong inhibitors or strong inducers of cytochrome (CYP) enzymes (also known as CYP P450 enzymes) during the 30 days before the first dose of study medication; use of any other prescription or OTC medicine (with the exception of acetaminophen (paracetamol)), including dietary supplements or herbal remedies, during the 7 days before the dose of study medication.
- Pregnant or breastfeeding women.
- Consumption of certain foods or beverages before the first dose and throughout the study period.
- Loss of more than 400 mL blood or donation of blood, plasma, platelets, or any other blood components during the 3 months before the first dose of study medication, or unwilling to abstain from doing so during the study and for 3 months after receipt of study medication.
- Abuse of drugs or alcohol during the 2 years before the first dose of study medication, or intake of more than 21 units of alcohol weekly for male subjects and 14 units of alcohol weekly for female subjects.
- Use of tobacco products or nicotine-containing products during the 3 months before the first dose of study medication and during the study.
- Evidence of drug or alcohol abuse at screening or admission.
- Likely possibility that the volunteer will not cooperate with the requirements of the protocol.
- Objection by General Practitioner (GP) to the volunteer entering the study.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: DS-1971a (Low Dose)
Participants in Cohort 1 who receive a low dose of DS 1971a in an oral suspension
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DS 1971a is supplied as a powder or crystals and will be given as an oral suspension
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Sperimentale: DS-1971a (Mid dose)
Participants in Cohort 2 who receive a mid dose of DS 1971a in an oral suspension
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DS 1971a is supplied as a powder or crystals and will be given as an oral suspension
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Sperimentale: DS-1971a (High dose)
Participants in Cohort 3 who receive a high dose of DS 1971a in an oral suspension
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DS 1971a is supplied as a powder or crystals and will be given as an oral suspension
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Sperimentale: Pooled placebo
Participants in Cohort 1, 2 or 3 who receive matching DS-1971a Placebo
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Placebo matching DS-1971a suspension
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of participants with at least one Treatment Emergent Adverse Event (TEAEs)
Lasso di tempo: 14 days
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TEAEs are adverse events that began or got worse after treatment began.
Clinically significant changes in laboratory tests and/or physical examinations are considered adverse events.
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14 days
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Cmax of DS-1971a
Lasso di tempo: Day 1 and Day 14
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Cmax is the highest concentration of the drug in the blood
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Day 1 and Day 14
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Tmax of DS-1971a
Lasso di tempo: Day 1 and Day 14
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Tmax is the time it takes for Cmax to be reached
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Day 1 and Day 14
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Area Under Curve at steady state (AUCtau) of DS-1971a
Lasso di tempo: Day 1 and Day 14
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AUCtau is the area under the plasma concentration-time curve at steady state.
In pharmacokinetics, steady state refers to the situation where the overall intake of a drug is about even with the rate it is being eliminated from the body.
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Day 1 and Day 14
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Area under the Curve (additional measures) for DS-1971a
Lasso di tempo: Day 1 and Day 14
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Additional AUC measures include AUC0-24 (to 24 hours), AUClast (to the last observable measure), AUC0-inf (to infinity), and AUCextr (from AUClast to infinity)
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Day 1 and Day 14
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Tmax of DS-1971a metabolites M1 and M2
Lasso di tempo: Day 1 and Day 14
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Tmax of metabolites M1 and M2 characterized by Tmax
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Day 1 and Day 14
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Cmax of DS-1971a metabolites M1 and M2
Lasso di tempo: Day 1 and Day 14
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Cmax of metabolites M1 and M2 characterized by Cmax
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Day 1 and Day 14
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AUC of DS-1971a metabolites M1 and M2
Lasso di tempo: Day 1 and Day 14
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AUC measures include AUCtau, AUC0-24, AUClast, AUC0-inf
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Day 1 and Day 14
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2015
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
28 settembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
29 settembre 2015
Primo Inserito (Stima)
1 ottobre 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
28 aprile 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 aprile 2017
Ultimo verificato
1 aprile 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- DS1971-A-E106
- 2015-002885-22 (Numero EudraCT)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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