XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers
15 de fevereiro de 2018 atualizado por: PHARMENTERPRISES LLC
A Double-blind, Randomized, Placebo-controlled Study of the Safety and Tolerability of Increasing Doses of XC8 After Single and Repeated Oral Administration in Healthy Volunteers
A double-blind, randomized, placebo-controlled, Phase I clinical study of the safety and tolerability of increasing doses of XC8 after single and repeated oral administration in healthy volunteers. The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
The primary objective of the study was to evaluate the safety and tolerability profile for XC8 after single and multiple administration based on the frequency and severity of adverse events and changes in vital signs, laboratory results, electrocardiography and results of the physical examination.
The secondary objective of the study was to assess pharmacokinetics of XC8.
Visão geral do estudo
Descrição detalhada
One Russian center was approved for participation in this study. One center was initiated. Healthy volunteers were enrolled in 1 center. The study consisted of 4 periods: screening, single administration, multiple administration and follow-up.
All eligible subjects were randomized into the study in appropriate cohort groups sequentially.
Cohort 1 - XC8 or Placebo 2 mg once and then daily 14 days after a 6-day break; Cohort 2 - XC8 or Placebo 10 mg once and then daily during 14 days after a 6-day break; Cohort 3 - XC8 or Placebo 50 mg once and then daily during 14 days after a 6-day break; Cohort 4 - XC8 or Placebo 200 mg once and then daily during 14 days after a 6-day break.
The decision regarding increasing of the study drug dose for a subsequent cohort was made by the Data Safety Monitoring Committee on the basis of preliminary safety results assessment.
A total of 20 volunteers received XC8 (2 mg, 10 mg, 50 mg or 200 mg) and a total of 8 volunteers received the placebo during the study participation. The follow-up period lasted for 4 weeks.
Tipo de estudo
Intervencional
Inscrição (Real)
28
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Moscow, Federação Russa, 119435
- SBEI HPE The First Moscow State Medical University n.a. Sechenov of Ministry of Health of Russian Federation, University Hospital #2, Department of Development of New Medicines
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Non-smoking men aged 18 to 50 years (inclusive);
- Verified diagnosis "healthy" according to standard clinical, laboratory and instrumental methods of examination;
- Body mass index of 19 to 30 kg/m2 (inclusive);
- Consent to use reliable methods of contraception during the study and 3 months after its completion (condoms with spermicide);
- Signed patient information sheet and informed consent form for participation in the study.
Exclusion Criteria:
- Hepatic disorder or renal disease; any other disease that, in the opinion investigator, may affect the results of the study, or may lead to the health aggravation during the study;
- Laboratory abnormalities at screening;
- Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
- Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;
- The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
- Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening;
- History of allergies (including medicines and food products);
- Symptomatic rhinitis in anamnesis during 2 years prior to screening (allergic rhinitis, non-allergic rhinitis or pollinosis);
- Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
- Participation in other clinical trials or taking the study drug during 3 months before screening;
- Impossibility to understand or follow protocol instructions;
- Smoking 3 months before screening;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- Acute infectious diseases less than 4 weeks before the start of the study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: XC8 2 mg
Cohort 1: 6 subjects were randomized in a 2:1 ratio to be treated either with 2 mg XC8 (4 subjects) or placebo (2 subjects, see placebo arm).
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Outros nomes:
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Experimental: XC8 10 mg
Cohort 2: 6 subjects were randomized in a 2:1 ratio to be treated either with 10 mg XC8 (4 subjects) or placebo (2 subjects, see placebo arm).
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Outros nomes:
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Experimental: XC8 50 mg
Cohort 3: 6 subjects were randomized in a 2:1 ratio to be treated either with 50 mg XC8 (4 subjects) or placebo (2 subjects, see placebo arm).
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Outros nomes:
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Experimental: XC8 200 mg
Cohort 4: 10 subjects were randomized in a 4:1 ratio to be treated either with 200 mg XC8 (8 subjects) or placebo (2 subjects, see placebo arm).
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Outros nomes:
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Comparador de Placebo: Placebo
Placebo comparator arm consists of 8 subjects (2 subjects in each cohort).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Adverse events per treatment arm
Prazo: Change from pre-dose to Day 50
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Adverse events will be summarized descriptively by treatment arm.
Verbatim terms will be mapped to preferred terms and organ systems using the current Medical Dictionary for Regulatory Activities version.
For each preferred term, frequency counts and percentages will be calculated by cohort.The nature, severity, seriousness, and relationship to study medication will be summarized for all study subjects
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Change from pre-dose to Day 50
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Physical examination
Prazo: Day 1 till Day 36
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Physical examination results will be listed for following: general appearance, skin, head, eyes, ears, nose, throat, neck (including thyroid), lymph nodes, chest, heart, abdomen (including liver examination), extremities, and nervous system.
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Day 1 till Day 36
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12-lead ECG
Prazo: Change from pre-dose till Day 36
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12-lead ECG results will be analyzed descriptively
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Change from pre-dose till Day 36
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Pharmacokinetics of XC8 by assessing AUC0-inf
Prazo: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Area under the curve "concentration of the drug-time" from the time of administration of the drug till infinity
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Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Pharmacokinetics of XC8 by assessing Cmax
Prazo: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Maximum plasma concentration
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Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Pharmacokinetics of XC8 by assessing AUC0-t
Prazo: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Area under the curve "concentration of the drug-time" from the time of administration of the drug till the time (t) the last blood sampling
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Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Pharmacokinetics of XC8 by assessing Tmax
Prazo: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Time to maximum drug concentration in the blood plasma administration
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Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Pharmacokinetics of XC8 by assessing T1/2
Prazo: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Terminal elimination half-life
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Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Pharmacokinetics of XC8 by assessing kel
Prazo: Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Elimination rate constant
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Day 1 and 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 2 and Day 22 (24 hours ±10 minutes post dose), Day 3 (48 hours ±10 minutes post dose), Day 4 (72 hours ±10 minutes post dose), Day 8 to 12 and 15 (Pre dose)
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Pharmacokinetics of XC8 by assessing Cav
Prazo: Day 8 to 12 and 15 (Pre dose); Day 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 22 (24 hours ±10 minutes post dose
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Average concentration over one dosing interval
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Day 8 to 12 and 15 (Pre dose); Day 21 (Pre dose, and 20 min, 40 min, 1, 2, 4, 6 and 10 hours post dose), Day 22 (24 hours ±10 minutes post dose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
14 de fevereiro de 2015
Conclusão Primária (Real)
7 de julho de 2015
Conclusão do estudo (Real)
7 de julho de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
11 de janeiro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de fevereiro de 2018
Primeira postagem (Real)
22 de fevereiro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de fevereiro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de fevereiro de 2018
Última verificação
1 de fevereiro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PULM-XC8-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Placebo
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