- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01498861
Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol
17 de maio de 2012 atualizado por: ViiV Healthcare
A Double-Blind Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol When Co-administered With Dolutegravir in Healthy Adult Female Subjects
Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection.
DTG will likely be used in women on oral contraceptives (OC) for birth control.
Based on accumulated non-clinical and clinical drug metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between DTG and most widely used OC drugs.
The primary objective of this study is to evaluate the effect of DTG administration on the pharmacokinetics and pharmacodynamics of a commonly used oral contraceptive product, Ortho-Cyclen (combination of norgestimate and ethinyl estradiol), in healthy female subjects.
Each subject will participate in a Run-in period (if needed), followed by two treatment periods.
Approximately 16 subjects will be randomized in a cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with Placebo for 10 days and switch to the alternate treatment for another 10 days.
Subjects will return to the study center for final follow up evaluations 7 - 14 days after the final dose of study medication.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
16
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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Florida
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Miami, Florida, Estados Unidos, 33169
- GSK Investigational Site
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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 40 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN)
- Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied except for ALT, alkaline phosphatase and bilirubin as above may be included only if the Investigator feels that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Female, between 18 and 40 years of age inclusive, at the time of signing the informed consent.
- Women of childbearing potential must use OC Ortho-Cyclen in combination with one of the following appropriate contraceptive methods:a)Complete abstinence from intercourse for at least 14 days prior to the first dose of investigational product (Day 1 of Period 1), throughout the study, and for the subsequent poststudy monitoring or; b) A barrier method plus a spermicide (e.g., condom or diaphragm with spermicidal foam/gel/cream/ suppository for at least 14 days prior to the first dose of investigational product [Day 1 of Period 1]) throughout the study, and for the subsequent poststudy monitoring or; c)Sterilization (vasectomy) of male partner prior to commencement of female subject's last normal menstrual period prior to administration of study drug, and the male partner is the sole partner for that female subject.
- The subject's BMI is 19 to 30 kg/m2 and body weight ≥50 kg (110 lbs) and <114 kg (<250 lbs);
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Single QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception (see inclusion criteria) from at least 14 days prior to the first dose of investigational product until completion of the follow-up visit;
- Pregnant females as determined by positive hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of any condition that would contraindicate OC administration (including hypertension, stroke, ischemic heart disease, venous thromboembolism or family history of thromboembolism, known factor V Leiden mutation or other gene mutations associated with increased risk of thromboembolism, migraine headaches, carcinoma of the breast, liver or endometrium, gallbladder disease, history of undiagnosed abnormal uterine bleeding, etc.).
- If heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- Unwilling to abstain from tobacco use from the screening visit until the follow-up visit.
- Females with conditions or concurrent medications that could adversely affect hormone levels e.g. oopherectomies and females receiving drug eluting IUDs (e.g. Mirena).
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: Run-In Period
Ortho-Cyclen for 21 days.
Only for subjects who are not already taking Ortho-Cyclen prior to the study
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Ortho-cyclen is an oral contraceptive.
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Experimental: Sequence AB
Subjects will take Ortho-Cyclen once a day from Day 1-21 of their menstrual cycle.
In addition they will take dolutegravir 50 mg twice a day from Days 1-10 and placebo twice a day from Day 12-21
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Ortho-cyclen is an oral contraceptive.
Dolutegravir is an experimental HIV drug
Outros nomes:
Placebo is a tablet with no drug in it
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Experimental: Sequence BA
Subjects will take Ortho-Cyclen once a day from Day 1-21 of their menstrual cycle.
In addition they will take placebo twice a day from Days 1-10 and dolutegravir 50 mg twice a day from Day 12-21
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Ortho-cyclen is an oral contraceptive.
Dolutegravir is an experimental HIV drug
Outros nomes:
Placebo is a tablet with no drug in it
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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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AUC(0-tau) of norelgestromin and ethinylestradiol after Ortho-Cyclen alone and after Ortho-Cyclen with dolutegravir
Prazo: Up to 24 hours post-dose
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Samples will be collected at predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 10 and 21
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Up to 24 hours post-dose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Safety and tolerability of all treatments as assessed by vital signs, AEs, and clinical laboratory tests
Prazo: Up to 8 weeks
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Up to 8 weeks
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Composite of norelgestromin pharmacokinetic parameters on Day 10 and Day 21: Cmax, Cmin, tmax, tmin and half life
Prazo: Up to 24 hours post dose
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Samples will be collected at predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 10 and 21
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Up to 24 hours post dose
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Predose serum levels of luteinizing hormone and follicle stimulating hormone from Periods 1 and 2
Prazo: predose on Days 1, 10, 11, 21 and 22
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Samples will be collected at predose on Days 1, 10, 11, 21 and 22
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predose on Days 1, 10, 11, 21 and 22
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Predose serum levels of progesterone from Periods 1 and 2
Prazo: predose on Days 1, 10, 11, 21 and 22
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Samples will be collected at predose on Days 1, 10, 11, 21 and 22
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predose on Days 1, 10, 11, 21 and 22
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Composite of dolutegravir pharmacokinetic parameters on Day 10 and Day 21: AUC(0-t), Cmax, tmax, Cmin, C0, Ct and CL/F
Prazo: Up to 12 hours post dose
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Samples will be collected at predose and at 1, 2, 3, 4, 6, 8, and 12 hours post dose on Day 10 and Day 21
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Up to 12 hours 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
1 de dezembro de 2011
Conclusão Primária (Real)
1 de março de 2012
Conclusão do estudo (Real)
1 de março de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
21 de dezembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de dezembro de 2011
Primeira postagem (Estimativa)
26 de dezembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de maio de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
17 de maio de 2012
Última verificação
1 de abril de 2012
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções transmitidas pelo sangue
- Doenças Transmissíveis
- Doenças Sexualmente Transmissíveis, Virais
- Doenças Sexualmente Transmissíveis
- Infecções por Lentivírus
- Infecções por Retroviridae
- Síndromes de Deficiência Imunológica
- Doenças do sistema imunológico
- Doenças de Vírus Lento
- Infecções por HIV
- Síndrome da Imunodeficiência Adquirida
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes Anti-Infecciosos
- Antivirais
- Inibidores Enzimáticos
- Agentes anti-HIV
- Antirretrovirais
- Agentes Antineoplásicos
- Inibidores da Topoisomerase II
- Inibidores da Topoisomerase
- Agentes antibacterianos
- Agentes Contraceptivos Hormonais
- Anticoncepcionais
- Agentes de Controle Reprodutivo
- Anticoncepcionais Orais Combinados
- Anticoncepcionais Orais
- Agentes Contraceptivos, Feminino
- Inibidores da Integrase do HIV
- Inibidores de integrase
- Moxifloxacino
- Norgestimato, combinação de drogas de etinilestradiol
- Dolutegravir
Outros números de identificação do estudo
- 111855
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 Ortho-Cyclen
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Sahlgrenska University Hospital, SwedenRecrutamentoOsteoartrite do joelho | Osteoartrite do quadrilSuécia
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AL YousefKing Abdullah International Medical Research CenterDesconhecidoMá oclusão, Classe I de Angle | Má oclusão; Ângulo Classe II Divisão 1Arábia Saudita
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The University of QueenslandKing's College London; UMC Utrecht; Julius Clinical; FightMNDConcluídoDoença do neurônio motor | Esclerose Lateral AmiotróficaHolanda, Reino Unido, Austrália
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Bristol-Myers SquibbConcluído
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Janssen Research & Development, LLCConcluído
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Bristol-Myers SquibbConcluídoInfecções por HIVEstados Unidos
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Eli Lilly and CompanyConcluído
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Virginia Commonwealth UniversityConcluídoDoenças cardiovasculares | Obesidade | Resistência a insulina | Síndrome Metabólica XEstados Unidos
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Virginia Commonwealth UniversityAmerican Heart AssociationConcluídoRisco Cardiovascular | Sensibilidade à Insulina | Transtorno da PerimenopausaEstados Unidos
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University of ChicagoOrganonConcluídoConformidade com o controle de natalidadeEstados Unidos