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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02533427




Registration number
NCT02533427
Ethics application status
Date submitted
24/08/2015
Date registered
26/08/2015
Date last updated
12/02/2019

Titles & IDs
Public title
Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
Scientific title
A Phase 1, Open-Label, Drug Interaction Study Evaluating the Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
Secondary ID [1] 0 0
GS-US-367-1909
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HCV Infection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SOF/VEL/GS-9857
Treatment: Drugs - GS-9857
Treatment: Drugs - Norgestimate/ethinyl estradiol

Experimental: SOF/VEL/GS-9857+GS-9857 - Part A: Participants without a documented history of taking norgestimate/ethinyl estradiol for at least one menstrual cycle will receive norgestimate/ethinyl estradiol. Participants with a documented history of taking norgestimate/ethinyl estradiol may enroll directly into Part B of the study.
Part B: Participants will continue taking norgestimate/ethinyl estradiol for the remainder of the study and will receive SOF/VEL/GS-9857 FDC plus GS-9857.


Treatment: Drugs: SOF/VEL/GS-9857
SOF/VEL/GS-9857 (400/100/100 mg) FDC tablet administered orally once daily

Treatment: Drugs: GS-9857
GS-9857 100 mg tablet administered orally once daily

Treatment: Drugs: Norgestimate/ethinyl estradiol
Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
PK parameter: AUCtau for norgestimate (if possible), norelgestromin, norgestrel, and ethinyl estradiol - AUCtau is defined as concentration of drug over time.
Timepoint [1] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Primary outcome [2] 0 0
PK parameter: Ctau for norgestimate (if possible), norelgestromin, norgestrel, and ethinyl estradiol - Ctau is defined as the observed drug concentration at the end of the dosing interval.
Timepoint [2] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Primary outcome [3] 0 0
PK parameter: Cmax of norgestimate (if possible), norelgestromin, norgestrel, and ethinyl estradiol - Cmax is defined as the maximum observed plasma concentration of drug.
Timepoint [3] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [1] 0 0
Incidence of adverse events
Timepoint [1] 0 0
Up to 84 days
Secondary outcome [2] 0 0
Incidence of laboratory abnormalities - The percentage of participants experiencing any clinically significant laboratory abnormality will be summarized.
Timepoint [2] 0 0
Up to 84 days
Secondary outcome [3] 0 0
PK parameter: Tmax of norgestimate (if possible), norelgestromin, norgestrel, ethinyl estradiol, SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - Tmax is defined as the time (observed time point) of Cmax.
Timepoint [3] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [4] 0 0
PK parameter: Tlast of norgestimate (if possible), norelgestromin, norgestrel, ethinyl estradiol, SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - Tlast is defined as the time (observed time point) of Clast (last observed quantifiable plasma concentration of the drug).
Timepoint [4] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [5] 0 0
PK parameter: ?z for norgestimate (if possible), norelgestromin, norgestrel, ethinyl estradiol, SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - ?z is defined as the terminal elimination rate constant.
Timepoint [5] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [6] 0 0
PK parameter: CLss/F for norgestimate (if possible), norelgestromin, norgestrel, ethinyl estradiol, SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - CLss/F is defined as the apparent oral steady-state clearance after administration of the drug.
Timepoint [6] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [7] 0 0
PK parameter: t1/2 of norgestimate (if possible), norelgestromin, norgestrel, ethinyl estradiol, SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - t1/2 is defined as the estimate of the terminal elimination half-life of the drug in plasma.
Timepoint [7] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [8] 0 0
PK parameter: Cmax of SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - Cmax is defined as the maximum observed plasma concentration of drug.
Timepoint [8] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [9] 0 0
PK parameter: Ctau for SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - Ctau is defined as the observed drug concentration at the end of the dosing interval.
Timepoint [9] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose
Secondary outcome [10] 0 0
PK parameter: AUCtau for SOF (and its metabolites GS-566500 and GS-331007), VEL, and GS-9857 (and its metabolites if appropriate) - AUCtau is defined as concentration of drug over time.
Timepoint [10] 0 0
Predose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours postdose

Eligibility
Key inclusion criteria
- Premenopausal female

- Must have a calculated 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/GS-9857 fixed-dose
combination (FDC) + GS-9857 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/GS-9857+GS-9857.
Trial website
https://clinicaltrials.gov/show/NCT02533427
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Luisa Stamm, MD, PhD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications