A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Taken Up Into the Blood in Healthy Adults
A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 4-SEQUENCE SINGLE-DOSE CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF PRIFETRISTAT DRUG PRODUCT DIFFERING IN PARTICLE SIZE DISTRIBUTION
The purpose of this study is to understand the relative amount of drug that enters bloodstream from prifetrastat product lots differing in active ingredient particle size distribution.
The study is seeking participants who are:
Healthy males and females of non-childbearing potential >=18 years of age at screening
Participants in the study will receive a single dose of prifetrastat by mouth. After at least 14 days, they will receive another dose of prifetrastat by mouth. Each dose received by the patient will be in tablet form. The sequence in which tablets are given will be random.
The study will help understand how the difference in particle size distributions of the tablets may, or may not, affect how the drug is absorbed, processed, and eliminated by the body.
Participants will remain in the study clinic for 21 days. However, they may be permitted to leave between periods, and will have one follow-up contact.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Pfizer CT.gov Call Center
- 電話番号:1-800-718-1021
- メール:ClinicalTrials.gov_Inquiries@pfizer.com
研究場所
-
-
Bruxelles-capitale, Région de
-
Brussels、Bruxelles-capitale, Région de、ベルギー、B-1070
- 募集
- Pfizer Clinical Research Unit - Brussels
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion
- Females of non-childbearing potential and males >=18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- BMI of 18-32 kilogram per meter square(Kg/m^2); and a total body weight >50 kg (110 lb).
Exclusion
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
- Prior use of epigenetic modifying agents. Participants will only be permitted to enroll in a single arm of this study (cannot participate in Arm 1 and Arm 2).
- Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of prifetrastat
- Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.
研究計画
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Arm 1 prifetrastat
Crossover
|
Reference Treatment
Test 1 Treatment
|
|
アクティブコンパレータ:Arm 2 prifetrastat
Crossover
|
Reference Treatment
Test 2 Treatment
|
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 |
|---|---|---|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
時間枠:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment
時間枠:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 1 treatment of prifetrastat (AUClast If data does not permit AUCinf)
時間枠:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment
時間枠:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 2 treatment of prifetrastat (AUClast If data does not permit AUCinf)
時間枠:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
|
Maximum Observed Plasma Concentration (Cmax) profile of Test 2 prifetrastat treatment
時間枠:Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
Cmax was the maximum observed plasma concentration directly observed from data.
|
Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
時間枠:Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
時間枠:Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants With Clinically Significant Abnormalities in Vital Signs
時間枠:Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
時間枠:Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
|
Number of Participants With Clinically Significant Physical Examination Abnormalities
時間枠:Up to Day 35 after the last dose of study intervention in Period 2
|
Up to Day 35 after the last dose of study intervention in Period 2
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。