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Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study (DDI-COC)

12 de junho de 2018 atualizado por: Aquinox Pharmaceuticals (Canada) Inc.

Open-Label, Fixed-Sequence 3-Period Study to Determine the Effects of Repeated Oral Dosing of AQX-1125 on the Pharamacokinetics, Safety and Tolerability of a Combination Oral Contraceptive in Healthy Female Subjects

This is an open-label, fixed sequence, 4 cycle, drug-drug interaction (DDI) study of AQX-1125 in healthy female subjects on combination oral contraceptives (COC).

Visão geral do estudo

Tipo de estudo

Intervencional

Inscrição (Real)

32

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

      • Groningen, Holanda
        • PRA Health Sciences - Early Development Serices

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 45 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Aged 18-45 years, inclusive, at time of signing Informed Consent
  • Adult females of child bearing potential, who are non-pregnant and non-lactating, and must agree to use adequate additional contraception from the start of Treatment Period A until 90 days after the last dose of AQX-1125
  • BMI 18.0 - 35.0 kg/m2
  • Good physical and mental health based on medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the investigator

Exclusion Criteria:

  • Previous participation in the current study
  • Any clinically significant history of breakthrough bleeding
  • Using tobacco or other nicotine containing products within 12 months prior to the first study-specific COC-cycle intake
  • History of alcohol abuse or drug addiction
  • Positive drug and alcohol screen at screening and (each) admission to the clinical research center
  • Average intake of more than 24 units of alcohol per week
  • Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
  • Participation in a drug study within 30 days prior to screening. Participation in more than 2 other drug studies in the 10 months prior to (the first) drug administration in the current study
  • Donation or loss of more than 100 mL of blood within 60 days prior to the start of Treatment Period A, on Day 1. Donation or loss of more than 1.0 liters of blood in the 10 months prior to the start of Treatment Period A, on Day 1
  • Significant and/or acute illness within 5 days prior to Day 1 in Treatment Period A, that may impact safety assessments, in the opinion of the investigator
  • Unsuitable veins for blood sampling

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
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Pre-Treatment, Treatment Cycles A & B

Pre-Treatment: Two cycles of a combined oral contraceptive (COC) taken orally once daily for 21 days followed by 7 COC-free days.

Treatment Period A: COC containing taken orally once daily for 21 days followed by 7 COC-free days.

Treatment Period B: COC taken orally once daily for 21 days, with once daily oral 200 mg AQX-1125 (2 x 100 mg tablets) co-administered from Day 13 to 21, followed by 7 COC-free days

Investigational Drug
COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Time to attain maximum observed plasma concentration (tmax) of COC taken with AQX-1125
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Terminal elimination rate constant (Kel) of COC taken with AQX-1125
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Terminal elimination half-life (t1/2) of COC taken with AQX-1125
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
8 Weeks (from start of treatment period A to completion of treatment period B)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Safety and tolerability of AQX-1125 200 mg qd administered with the COC
Prazo: 16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
Safety and tolerability will be assessed by the severity and frequency of adverse events, which will include any abnormal clinically significant vital signs, laboratory tests, electrocardiogram and physical examination findings
16 weeks (from start of pre-treatment cycle 1 to completion of treatment period B)
Maximum observed plasma concentration (Cmax) of AQX-1125 taken with COC
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Time to attain maximum observed plasma concentration (tmax) of AQX-1125 taken with COC
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Terminal elimination rate constant (Kel) of AQX-1125 taken with COC
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
8 Weeks (from start of treatment period A to completion of treatment period B)
Terminal elimination half-life (t1/2) of AQX-1125 taken with COC
Prazo: 8 Weeks (from start of treatment period A to completion of treatment period B)
To assess the PK of 200 mg AQX-1125 qd when given together with the COC
8 Weeks (from start of treatment period A to completion of treatment period B)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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)

22 de novembro de 2017

Conclusão Primária (Real)

29 de março de 2018

Conclusão do estudo (Real)

5 de abril de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

19 de março de 2018

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de março de 2018

Primeira postagem (Real)

27 de março de 2018

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de junho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de junho de 2018

Última verificação

1 de junho de 2018

Mais Informações

Termos relacionados a este estudo

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

produto fabricado e exportado 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 AQX-1125

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