Health TrialsbyHealthPanel

Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives

ConditionAutosomal Dominant Polycystic Kidney Disease (ADPKD)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorVertex Pharmaceuticals Incorporated

About this trial

The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m²), inclusive

A total body weight of greater than (>) 50 kg

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • VX-407

    Drug

    Tablets for Oral Administration.

  • LNG/EE

    Drug

    Combination Tablets for Oral Administration.

  • NGM/EE

    Drug

    Combination Tablets for Oral Administration.

  • NET/EE

    Drug

    Combination Tablets for Oral Administration.

  • DRSP/EE

    Drug

    Combination Tablets for Oral Administration.

Treatment groups

148 Participants
are divided into 4 treatment groups
Group A: Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE)Experimental treatment 2 interventions
Group B: Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE)Experimental treatment 2 interventions
Group C: Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE)Experimental treatment 2 interventions
Group D: Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407

Time frame
From Day 1 up to Day 7 and Day 21 up to Day 27
2

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

Time frame
From Day 1 up to Day 9 and Day 23 up to Day 31
3

Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407

Time frame
From Day 1 up to Day 5 and Day 19 up to Day 23
4

Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407

Time frame
From Day 1 up to Day 7 and Day 21 up to Day 27

Secondary outcomes

1

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Day 36
2

Part B (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 Up to Day 39
3

Part C (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Day 32
4

Part D (Optional): Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame
From Day 1 up to Day 36

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vertex Pharmaceuticals Incorporated

Lead sponsor

Source ClinicalTrials.gov
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