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

12. juni 2018 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum observed plasma concentration (Cmax) of COC taken with AQX-1125
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and tolerability of AQX-1125 200 mg qd administered with the COC
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. november 2017

Primær færdiggørelse (Faktiske)

29. marts 2018

Studieafslutning (Faktiske)

5. april 2018

Datoer for studieregistrering

Først indsendt

19. marts 2018

Først indsendt, der opfyldte QC-kriterier

23. marts 2018

Først opslået (Faktiske)

27. marts 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2018

Sidst verificeret

1. juni 2018

Mere information

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Kliniske forsøg med AQX-1125

Abonner