Phase 1
Completed N=15
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
HCV Infection
Source: ClinicalTrials.gov NCT02533427 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin — 13757.4; 14690.4 hours*picogram/milliliter (h*pg/mL)
Summary
This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter: AUCtau of Norelgestromin |
13757.4; 14690.4 | — |
| PRIMARY PK Parameter: AUCtau of Norgestrel |
41.1; 47.3 | — |
| PRIMARY PK Parameter: AUCtau of Ethinyl Estradiol |
835.2; 871.4 | — |
| PRIMARY Pharmacokinetic (PK) Parameter: AUCtau of Norgestimate |
0.2; 0.5 | — |
| PRIMARY PK Parameter: Cmax of Norelgestromin |
1080.9; 1162.2 | — |
| PRIMARY PK Parameter: Cmax of Norgestrel |
2.0; 2.3 | — |
| PRIMARY PK Parameter: Cmax of Ethinyl Estradiol |
68.4; 80.6 | — |
| PRIMARY PK Parameter: Cmax of Norgestimate |
0.0; 0.1 | — |
| PRIMARY PK Parameter: Ctau of Norelgestromin |
364.1; 413.9 | — |
| PRIMARY PK Parameter: Ctau of Norgestrel |
1.5; 1.8 | — |
| PRIMARY PK Parameter: Ctau of Ethinyl Estradiol |
19.7; 18.2 | — |
| PRIMARY PK Parameter: Ctau of Norgestimate |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Experienced Treatment-Emergent Adverse Events |
66.7; 93.3 | — |
| SECONDARY Percentage of Participants Who Experienced Laboratory Abnormalities |
60.0; 53.3; 13.3; 6.7; 13.3; 0.0 | — |
| SECONDARY PK Parameter: Tmax of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate |
3.00; 3.00; 4.00; 4.00; 3.00; 2.00 | — |
| SECONDARY PK Parameter: Tlast of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate |
24.00; 24.00; 24.00; 24.00; 24.00; 24.00 | — |
| SECONDARY PK Parameter: λz of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate |
0.035; 0.025; 0.016; 0.012; 0.053; 0.059 | — |
| SECONDARY PK Parameter: t1/2 of Norelgestromin, Norgestrel, Ethinyl Estradiol, and Norgestimate |
18.91; 28.95; 33.76; 57.42; 13.68; 10.78 | — |
| SECONDARY PK Parameter: CLss/F Ethinyl Estradiol, and Norgestimate |
34226.8; 32000.0; 1285855.5; 617498.8 | — |
| SECONDARY PK Parameter: Cmax of Sofosbuvir (SOF), SOF Metabolites (GS-566500 and GS-331007), Velpatasvir (VEL), and Voxilaprevir (VOX) |
967.6; 491.1; 979.4; 853.3; 512.4 | — |
| SECONDARY PK Parameter: Tmax of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX |
2.50; 4.00; 4.00; 4.00; 6.00 | — |
| SECONDARY PK Parameter: Tlast of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX |
6.00; 16.00; 24.00; 24.00; 24.00 | — |
| SECONDARY PK Parameter: Ctau of SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX |
10.6; 323.1; 154.6; 56.1 | — |
| SECONDARY PK Parameter: λz of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX |
1.160; 0.247; 0.020; 0.037; 0.077 | — |
| SECONDARY PK Parameter: AUCtau of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX |
1997.2; 2769.3; 12098.9; 8226.3; 3857.9 | — |
| SECONDARY PK Parameter: CLss/F of SOF, VEL, and VOX |
218383.1; 12757.3; 56071.5 | — |
| SECONDARY PK Parameter: t1/2 of SOF, SOF Metabolites (GS-566500 and GS-331007), VEL, and VOX |
0.68; 2.70; 30.06; 19.75; 8.51 | — |
Eligibility Criteria
Inclusion Criteria
- Premenopausal female
- Must have a calculated body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m^2 at screening
- Must have a negative serum pregnancy test at screening and urine pregnancy test at Day -1
- Be willing and able to comply with all study requirements.
Exclusion Criteria
- Lactating female
- Have a history of any of the following:
- Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
- Known hypersensitivity to the study drugs, the metabolites or formulation excipients
- Believed, by the study investigator, to be inappropriate for study participation for any reason
Data sourced from ClinicalTrials.gov (NCT02533427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.