- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Groningen, Pays-Bas
- PRA Health Sciences - Early Development Serices
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
Délai: 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
Délai: 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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Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of COC taken with AQX-1125
Délai: 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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Terminal elimination rate constant (Kel) of COC taken with AQX-1125
Délai: 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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Terminal elimination half-life (t1/2) of COC taken with AQX-1125
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Safety and tolerability of AQX-1125 200 mg qd administered with the COC
Délai: 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
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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
Délai: 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
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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 AQX-1125 taken with COC
Délai: 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
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Area under the plasma concentration-time curve up to 24 hours (AUC0-24) of AQX-1125 taken with COC
Délai: 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
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Terminal elimination rate constant (Kel) of AQX-1125 taken with COC
Délai: 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)
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Terminal elimination half-life (t1/2) of AQX-1125 taken with COC
Délai: 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
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8 Weeks (from start of treatment period A to completion of treatment period B)
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AQX-1125-104
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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