- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03478020
Oral AQX-1125 and Combination Oral Contraceptive Drug-Drug Interaction Study (DDI-COC)
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Groningen, Holanda
- PRA Health Sciences - Early Development Serices
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
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
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 |
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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)
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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)
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To assess the effect of multiple doses of 200 mg AQX-1125 once daily (qd) on the pharmacokinetics (PK) of the COC
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8 Weeks (from start of treatment period A to completion of treatment period B)
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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)
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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
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8 Weeks (from start of treatment period A to completion of treatment period B)
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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
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8 Weeks (from start of treatment period A to completion of treatment period B)
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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)
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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)
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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)
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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
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AQX-1125-104
Informações sobre medicamentos e dispositivos, documentos de estudo
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