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The purpose of the study is to evaluate the effect of VX-407 on the pharmacokinetics of levonorgestrel (LNG) and ethinyl estradiol (EE), norgestimate (NGM) and EE, norethindrone (NET) and EE and drospirenone (DRSP) and EE. Also, to evaluate the safety and tolerability of co-administration of VX-407 with LNG/EE, NGM/EE, NET/EE and DRSP/EE.
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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE) | Experimental | Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state. |
|
| Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE) | Experimental | Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state. |
|
| Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE) | Experimental | Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state. |
|
| Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE) | Experimental | Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-407 | Drug | Suspension for oral administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of LNG and EE in the Absence and Presence of VX-407 | 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 and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 7 and Day 21 up to Day 27 | |
| Part B (Optional): Cmax of Norelgestromin (NGMN) and Norgestrel (NG) (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 9 and Day 23 up to Day 31 | |
| Part B (Optional): AUC0-inf of NGMN and NG (Active Metabolites of NGM) and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 9 and Day 23 up to Day 31 | |
| Part C (Optional): Cmax of NET and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 5 and Day 19 up to Day 23 | |
| Part C (Optional): AUC0-inf of NET and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 5 and Day 19 up to Day 23 | |
| Part D (Optional): Cmax of DRSP and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 7 and Day 21 up to Day 27 | |
| Part D (Optional): AUC0-inf of DRSP and EE in the Absence and Presence of VX-407 | From Day 1 up to Day 7 and Day 21 up to Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences - Kansas City | Overland Park | Kansas | 66212 | United States |
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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. |
|
| From Day 1 up to Day 40 |
| Part C (Optional): Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | From Day 1 up to Day 36 |
| Part A: Cmax of VX-407 | Days 9, 15 and 21 up to Day 27 |
| Part A: AUC0-inf of VX-407 | Days 9, 15 and 21 up to Day 27 |
| Part B (Optional): Cmax of VX-407 | Days 11, 17 and 23 up to Day 31 |
| Part B (Optional): AUC0-inf of VX-407 | Days 11, 17 and 23 up to Day 31 |
| Part C (Optional): Cmax of VX-407 | Days 7, 13 and 19 up to Day 23 |
| Part C (Optional): AUC0-inf of VX-407 | Days 7, 13 and 19 up to Day 23 |
| Part D (Optional): Cmax of VX-407 | Days 9, 15 and 21 up to Day 27 |
| Part D (Optional): AUC0-inf of VX-407 | Days 9, 15 and 21 up to Day 27 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |