A Study to Understand What the Body Does to the Study Medicine Called PF-07799544 When Taken by Healthy Adults
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-07799544 USING A 14C-MICROTRACER APPROACH
For this study, the study medicine has been specially prepared to contain radiolabeled carbon [14C]. [14C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study medicine does not change how the medicine works but helps to see how the medicine appears in the blood, urine, and stool after it is given. This type of study is called a radiolabeled study.
The purpose of this radiolabeled study is to learn how a certain amount of [14C] PF-07799544 is taken up into the bloodstream and removed from the body.
The study is seeking participants who are:
Male Ages 18 to 55 years of age confirmed to be healthy based on medical and physical tests.
Weigh more than 50 kilograms (kg) and have a body mass index of 17.5 to 32 kg per meter squared.
The study consists of two parts. In part one, all participants will receive one full dose of [14C]PF-07799544 by mouth.
Part two will begin at least 14 days after the dose in part one. In part two, participants will receive one full dose of PF-07799544 by mouth and one small dose of [14C] PF-07799544 by intravenous (IV) infusion. IV infusion will be directly injected into the veins.
To understand how the medicine is processed in the body, samples of blood, urine, feces, and vomit (if any) will be collected after each dose is given. This will help understand:
How much PF-07799544 is taken up into the bloodstream when taken by mouth compared to the dose given by IV How the body removes it from the blood steam. Participants will take part in the study for about 7 weeks, including evaluation at the start and follow-up period.
調査の概要
状態
条件
詳細な説明
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
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Wisconsin
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Madison、Wisconsin、アメリカ、53704
- 募集
- Fortrea Clinical Research Unit Inc.
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Males 18 to 55years of age, inclusive, 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 17.5-32 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
Total 14C radioactivity measured in plasma should not exceed 2.5 × standard biological carbon ratio.
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：非ランダム化
- 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 |
|---|---|
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実験的：Cohort 1
Participants will receive one dose of [14C] PF-07799544 by mouth in Period 1.
After a washout, participants will receive one dose of PF-07799544 by mouth and one intravenous (IV) infusion of [14C] PF-07799544 in Period 2
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A single oral dose of [14C] PF-07799544 will be administered as an extemporaneous suspension in Period 1.
A single oral dose of unlabeled PF-07799544 will be administered as extemporaneous solution in Period 2.
A single IV infusion of [14C] PF-07799544 will be administered at the approximate Tmax after administration of the unlabeled oral dose of PF-07248144 in Period 2.
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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 |
|---|---|---|
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Total recovery (%) of radioactivity in urine, feces and vomitus (if any), expressed as a percent of total oral radioactive dose administered.
時間枠：Period 1 pre-dose to maximum days 15
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To characterize the extent of excretion of total radioactivity in urine, feces and vomitus (if any) following administration of a single oral dose of [14C]PF-07799544.
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Period 1 pre-dose to maximum days 15
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Metabolic profiling/identification and determination of relative abundance of [14C]PF-07799544 and the metabolites of PF-07799544 in plasma, urine and feces, if possible.
時間枠：Period 1 pre-dose to maximum days 15
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To characterize the metabolic profile and identify the circulating and excreted metabolites of PF- 07799544 following administration of a single oral dose of [14C]PF-07799544.
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Period 1 pre-dose to maximum days 15
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The ratio of dose-normalized AUCinf (if data permit, otherwise AUClast) of oral PF-07799544 to IV [14C]PF-07799544.
時間枠：Period 2 pre-dose to maximum days 6.
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To determine the oral absolute bioavailability (F) of PF-07799544 from a single oral dose of PF-07799544 compared to a single IV microtracer of [14C]PF-07799544.
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Period 2 pre-dose to maximum days 6.
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The ratio of total recovered radioactivity 14C in urine following single dose administration of [14C]PF-07799544 orally in Period 1 and IV microtracer, microdose administration of [14C]PF-07799544 in Period 2.
時間枠：Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
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To determine the fraction of PF-07799544 dose absorbed (Fa) from a single oral dose of [14C]PF-07799544.
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Period 1 pre-dose to maximum days 15; Period 2 pre-dose to maximum days 6.
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Number of Participants With Treatment Emergent Adverse Events.
時間枠：Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants with Treatment Emergent Clinically Significant Laboratory Abnormalities.
時間枠：Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants With Treatment Emergent Clinically Significant Abnormal Vital Signs.
時間枠：Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants With Treatment Emergent Clinically Significant Physical Examination Abnormalities.
時間枠：Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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Number of Participants With Treatment Emergent Clinically Significant Abnormal ECG Measurements.
時間枠：Baseline up to 28 to 35 days post last study intervention dose.
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To evaluate the safety and tolerability of PF-07799544, administered as a single oral dose of [14C]PF-07799544 or a single oral dose of PF-07799544 followed by administration of a single IV microdose of [14C]PF-07799544.
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Baseline up to 28 to 35 days post last study intervention dose.
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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 (推定)
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
その他の研究ID番号
- C4901004
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
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Oral [14C] PF-07799544の臨床試験
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