Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol
2012年5月17日 更新者:ViiV Healthcare
A Double-Blind Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Norgestimate and Ethinyl Estradiol When Co-administered With Dolutegravir in Healthy Adult Female Subjects
Dolutegravir (DTG, GSK1349572 is an integrase inhibitor that is currently in Phase 3 clinical development for the treatment of HIV infection.
DTG will likely be used in women on oral contraceptives (OC) for birth control.
Based on accumulated non-clinical and clinical drug metabolism and pharmacokinetic data, there is a low likelihood of drug interaction between DTG and most widely used OC drugs.
The primary objective of this study is to evaluate the effect of DTG administration on the pharmacokinetics and pharmacodynamics of a commonly used oral contraceptive product, Ortho-Cyclen (combination of norgestimate and ethinyl estradiol), in healthy female subjects.
Each subject will participate in a Run-in period (if needed), followed by two treatment periods.
Approximately 16 subjects will be randomized in a cross-over fashion to either Ortho-Cyclen with DTG or Ortho-Cyclen with Placebo for 10 days and switch to the alternate treatment for another 10 days.
Subjects will return to the study center for final follow up evaluations 7 - 14 days after the final dose of study medication.
調査の概要
研究の種類
介入
入学 (実際)
16
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Florida
-
Miami、Florida、アメリカ、33169
- GSK Investigational Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
Inclusion Criteria:
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin greater than or equal to 1.5 times the upper limit of normal (ULN)
- Healthy female subjects, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied except for ALT, alkaline phosphatase and bilirubin as above may be included only if the Investigator feels that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Female, between 18 and 40 years of age inclusive, at the time of signing the informed consent.
- Women of childbearing potential must use OC Ortho-Cyclen in combination with one of the following appropriate contraceptive methods:a)Complete abstinence from intercourse for at least 14 days prior to the first dose of investigational product (Day 1 of Period 1), throughout the study, and for the subsequent poststudy monitoring or; b) A barrier method plus a spermicide (e.g., condom or diaphragm with spermicidal foam/gel/cream/ suppository for at least 14 days prior to the first dose of investigational product [Day 1 of Period 1]) throughout the study, and for the subsequent poststudy monitoring or; c)Sterilization (vasectomy) of male partner prior to commencement of female subject's last normal menstrual period prior to administration of study drug, and the male partner is the sole partner for that female subject.
- The subject's BMI is 19 to 30 kg/m2 and body weight ≥50 kg (110 lbs) and <114 kg (<250 lbs);
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Single QTcB < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception (see inclusion criteria) from at least 14 days prior to the first dose of investigational product until completion of the follow-up visit;
- Pregnant females as determined by positive hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of any condition that would contraindicate OC administration (including hypertension, stroke, ischemic heart disease, venous thromboembolism or family history of thromboembolism, known factor V Leiden mutation or other gene mutations associated with increased risk of thromboembolism, migraine headaches, carcinoma of the breast, liver or endometrium, gallbladder disease, history of undiagnosed abnormal uterine bleeding, etc.).
- If heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- Unwilling to abstain from tobacco use from the screening visit until the follow-up visit.
- Females with conditions or concurrent medications that could adversely affect hormone levels e.g. oopherectomies and females receiving drug eluting IUDs (e.g. Mirena).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:ランダム化
- 介入モデル:クロスオーバー割り当て
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
他の:Run-In Period
Ortho-Cyclen for 21 days.
Only for subjects who are not already taking Ortho-Cyclen prior to the study
|
Ortho-cyclen is an oral contraceptive.
|
実験的:Sequence AB
Subjects will take Ortho-Cyclen once a day from Day 1-21 of their menstrual cycle.
In addition they will take dolutegravir 50 mg twice a day from Days 1-10 and placebo twice a day from Day 12-21
|
Ortho-cyclen is an oral contraceptive.
Dolutegravir is an experimental HIV drug
他の名前:
Placebo is a tablet with no drug in it
|
実験的:Sequence BA
Subjects will take Ortho-Cyclen once a day from Day 1-21 of their menstrual cycle.
In addition they will take placebo twice a day from Days 1-10 and dolutegravir 50 mg twice a day from Day 12-21
|
Ortho-cyclen is an oral contraceptive.
Dolutegravir is an experimental HIV drug
他の名前:
Placebo is a tablet with no drug in it
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
AUC(0-tau) of norelgestromin and ethinylestradiol after Ortho-Cyclen alone and after Ortho-Cyclen with dolutegravir
時間枠:Up to 24 hours post-dose
|
Samples will be collected at predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 10 and 21
|
Up to 24 hours post-dose
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Safety and tolerability of all treatments as assessed by vital signs, AEs, and clinical laboratory tests
時間枠:Up to 8 weeks
|
Up to 8 weeks
|
|
Composite of norelgestromin pharmacokinetic parameters on Day 10 and Day 21: Cmax, Cmin, tmax, tmin and half life
時間枠:Up to 24 hours post dose
|
Samples will be collected at predose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 10 and 21
|
Up to 24 hours post dose
|
Predose serum levels of luteinizing hormone and follicle stimulating hormone from Periods 1 and 2
時間枠:predose on Days 1, 10, 11, 21 and 22
|
Samples will be collected at predose on Days 1, 10, 11, 21 and 22
|
predose on Days 1, 10, 11, 21 and 22
|
Predose serum levels of progesterone from Periods 1 and 2
時間枠:predose on Days 1, 10, 11, 21 and 22
|
Samples will be collected at predose on Days 1, 10, 11, 21 and 22
|
predose on Days 1, 10, 11, 21 and 22
|
Composite of dolutegravir pharmacokinetic parameters on Day 10 and Day 21: AUC(0-t), Cmax, tmax, Cmin, C0, Ct and CL/F
時間枠:Up to 12 hours post dose
|
Samples will be collected at predose and at 1, 2, 3, 4, 6, 8, and 12 hours post dose on Day 10 and Day 21
|
Up to 12 hours post dose
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年12月1日
一次修了 (実際)
2012年3月1日
研究の完了 (実際)
2012年3月1日
試験登録日
最初に提出
2011年12月21日
QC基準を満たした最初の提出物
2011年12月21日
最初の投稿 (見積もり)
2011年12月26日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年5月21日
QC基準を満たした最後の更新が送信されました
2012年5月17日
最終確認日
2012年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- RNAウイルス感染症
- ウイルス病
- 感染症
- 血液感染症
- 伝染病
- 性感染症、ウイルス
- 性感染症
- レンチウイルス感染症
- レトロウイルス感染症
- 免疫不全症候群
- 免疫系疾患
- 遅いウイルス病
- HIV感染症
- 後天性免疫不全症候群
- 薬の生理作用
- 薬理作用の分子機構
- 抗感染剤
- 抗ウイルス剤
- 酵素阻害剤
- 抗HIV薬
- 抗レトロウイルス剤
- 抗悪性腫瘍薬
- トポイソメラーゼ II 阻害剤
- トポイソメラーゼ阻害剤
- 抗菌剤
- 避妊薬、ホルモン
- 避妊薬
- 生殖制御剤
- 避妊薬、経口、併用
- 避妊薬、経口
- 避妊薬、女性
- HIV インテグラーゼ阻害剤
- インテグラーゼ阻害剤
- モキシフロキサシン
- ノルゲスチメート、エチニルエストラジオール配合剤
- ドルテグラビル
その他の研究ID番号
- 111855
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Ortho-Cyclenの臨床試験
-
The Hong Kong Polytechnic UniversityAston University; Queensland University of Technology; Menicon Co., Ltd.完了
-
Medical University of Vienna積極的、募集していない
-
University of HullHull University Teaching Hospitals NHS Trustわからない
-
The Hong Kong Polytechnic UniversityAston University; Queensland University of Technology募集