Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
25. august 2026 opdateret af: Vertex Pharmaceuticals Incorporated
A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply.
(That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
148
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Medical Information
- Telefonnummer: 617-341-6777
- E-mail: medicalinfo@vrtx.com
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
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Key Inclusion Criteria:
- Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2), inclusive
- A total body weight of greater than (>) 50 kg
Key Exclusion Criteria:
- History of febrile illness within 5 days before the first dose of study drug
- Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug
Other protocol defined Inclusion/Exclusion criteria will apply.
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
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Del A: VX-407 med Levonorgestrel/Ethinyl Estradiol (LNG/EE)
Deltagerne vil modtage en enkelt dosis LNG/EE på dag 1 og 21 i fastet tilstand.
Deltagerne vil også modtage VX-407 hver 12. time (Q12H) fra dag 8 til 26 i fastet tilstand.
|
Kombinationstabletter til oral administration.
Tablets for Oral Administration.
|
|
Eksperimentel: Del B (valgfrit): VX-407 med Norestimate/Ethinyl Estradiol (NGM/EE)
Deltagerne vil modtage en enkelt dosis af NGM/EE på dag 1 og 23 i fastet tilstand.
Deltagerne vil også modtage VX-407 Q12H fra dage 10 til 30 i fastet tilstand.
|
Kombinationstabletter til oral administration.
Tablets for Oral Administration.
|
|
Eksperimentel: Del C (valgfrit): VX-407 med Norethindrone/Ethinyl Estradiol (NET/EE)
Deltagerne vil modtage en enkelt dosis netto/EE på dag 1 og 19 i fastet tilstand.
Deltagerne vil også modtage VX-407 Q12H fra dag 6 til 22 i fastet tilstand.
|
Kombinationstabletter til oral administration.
Tablets for Oral Administration.
|
|
Eksperimentel: Del D (valgfrit): VX-407 med Drospirenon/Ethinyl Estradiol (DRSP/EE)
Deltagerne vil modtage en enkelt dosis af DRSP/EE på dag 1 og 21 i fastet tilstand.
Deltagerne vil også modtage VX-407 Q12H fra dag 8 til 26 i fastet tilstand.
|
Kombinationstabletter til oral administration.
Tablets for Oral Administration.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
|
Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 9 and Day 23 up to Day 31
|
From Day 1 up to Day 9 and Day 23 up to Day 31
|
|
Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 5 and Day 19 up to Day 23
|
From Day 1 up to Day 5 and Day 19 up to Day 23
|
|
Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
|
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
|
Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 9 and Day 23 up to Day 31
|
From Day 1 up to Day 9 and Day 23 up to Day 31
|
|
Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NET and EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 5 and Day 19 up to Day 23
|
From Day 1 up to Day 5 and Day 19 up to Day 23
|
|
Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of VX-407
Tidsramme: From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to Day 36
|
From Day 1 up to Day 36
|
|
Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 Up to Day 39
|
From Day 1 Up to Day 39
|
|
Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to Day 32
|
From Day 1 up to Day 32
|
|
Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: From Day 1 up to Day 36
|
From Day 1 up to Day 36
|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407
Tidsramme: Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
|
Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407
Tidsramme: Days 11, 17 and 23 up to Day 31
|
Days 11, 17 and 23 up to Day 31
|
|
Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407
Tidsramme: Days 7, 13 and 19 up to Day 23
|
Days 7, 13 and 19 up to Day 23
|
|
Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407
Tidsramme: Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
|
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
Tidsramme: Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
|
Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
Tidsramme: Days 11, 17 and 23 up to Day 31
|
Days 11, 17 and 23 up to Day 31
|
|
Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
Tidsramme: Days 7, 13 and 19 up to Day 23
|
Days 7, 13 and 19 up to Day 23
|
|
Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
Tidsramme: Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
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 (Anslået)
28. august 2026
Primær færdiggørelse (Anslået)
11. marts 2027
Studieafslutning (Anslået)
20. marts 2027
Datoer for studieregistrering
Først indsendt
25. august 2026
Først indsendt, der opfyldte QC-kriterier
25. august 2026
Først opslået (Faktiske)
28. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Ciliopatier
- Urogenitale sygdomme
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Genetiske sygdomme, medfødte
- Medfødte abnormiteter
- Abnormiteter, multiple
- Nyresygdomme, Cystisk
- Polycystiske nyresygdomme
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Polycystisk nyre, autosomal dominant
Andre undersøgelses-id-numre
- VX26-407-014
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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