Investigation Of The Effect Of Steady State Filibuvir On The Pharmacokinetics Of Oral Contraceptives (Levonorgestrel And Ethinyl Estradiol)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00918476
First received: June 9, 2009
Last updated: April 18, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to estimate the effect of filibuvir on the pharmacokinetics of ethinyloestradiol [EE] and levonorgestrel [LN], to assess the safety and tolerability of 600 mg BID of filibuvir in healthy women and to investigate the pharmacokinetics of 600 mg BID of filibuvir in healthy women.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: filibuvir + Oral Contraceptives |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open Label Fixed Sequence Study To Investigate The Effects Of Multiple Oral Doses Of Filibuvir On The Steady State Pharmacokinetics Of Oral Contraceptive Steroids In Healthy Female Subjects |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Ethinyl Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- AUCtau, Cmax, for LN and EE on Day 21 in Period 1 and Period 2. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- LN and EE - Tmax and t1/2 (if data permit) in Period 1 and Period 2. Filibuvir - AUCtau, Cmax, Cmin, and Tmax on Day 28 of Period 1 and Day 21 of Period 2. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- Safety (AE, lab, vital, ECG, etc). [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | June 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. filibuvir + Oral Contraceptives |
Drug: filibuvir + Oral Contraceptives
This is an open-label, fixed sequence study to investigate the effect of filibuvir (600 mg BID on the pharmacokinetics of oral contraceptives steroids. Sixteen subjects who have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 will be enrolled into the study. The study will be conducted over two 28 day menstrual cycles and Day 1 of each period is defined as the first day of dosing OC in each cycle. During the first cycle (Period 1), the subjects will receive OC QD for 21 days and filibuvir BID on Days 22 through 28. During the second cycle (Period 2) the subjects will receive OC QD and filibuvir BID for 21 days. The dosing of filibuvir will start in Period 1 (Days 22 - 28).
|
Detailed Description:
To investigate the effects of multiple oral doses of filibuvir on the steady state pharmacokinetics of oral contraceptive steroids in healthy female subjects.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy female subjects between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
- Subjects must have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1.
- Body Mass Index (BMI) of approximately 17.5 to 30.5 kg/m2; and a total body weight >45 kg.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- Must be willing to practice an alternative method of contraception for the duration of the study in addition to oral contraceptive use.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any medical reason which would contraindicate the administration of oral contraceptives (as per label). Including but not limited to history of unexplained vaginal bleeding, current breast cancer, active liver disease, uncontrolled hypertension, history of diabetes with vascular complications, history of venous thrombosis, stroke, ischemic heart disease, history of severe headaches with focal neurologic symptoms.
- Female subjects of non-childbearing potential who meet the following criteria:
- Post menopausal, aged between 45-55 who have been amenorrheic for >2 years and who meet the criteria for serum FSH levels (>30 IU/L), or
- Females who have undergone a hysterectomy, or
- Females who have undergone tubal ligation, or
- Females who have undergone bilateral oophorectomy.
- History of discontinued use of oral contraceptives for medical reasons.
- History of febrile illness within 5 days prior to the first dose.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00918476 History of Changes |
| Other Study ID Numbers: | A8121008 |
| Study First Received: | June 9, 2009 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Contraceptive Agents Contraceptives, Oral Ethinyl Estradiol Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013