Study of Midomafetamine in Healthy Adults
A Phase 1, Single-Center, Open-Label, 2-Cohort Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Midomafetamine at Therapeutic and Supratherapeutic Doses
This Phase 1 study is designed to evaluate the safety and tolerability of midomafetamine in healthy adult participants. The study will also assess how the drug is processed in the body and characterize its effects following administration at two dose levels, including evaluation of cardiac safety using electrocardiographic assessments.
This is a single-center, open-label study in which participants will be enrolled into one of two cohorts receiving either a therapeutic dose or a supratherapeutic dose of midomafetamine. Participants will receive study drug in a split dose administration (an initial dose followed by an additional dose 1.5 hours later) and will undergo clinical assessments, laboratory testing, electrocardiographic monitoring, and monitoring for adverse events.
Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
調査の概要
詳細な説明
This Phase 1 study is a dedicated safety investigation conducted in healthy adult participants to further characterize the safety and tolerability of midomafetamine under controlled dosing conditions. Participants will receive a split dose administration of midomafetamine (an initial dose of study drug followed by an additional dose 1.5 hours later) in sequential dose cohorts intended to achieve therapeutic and supratherapeutic systemic exposure.
Safety assessments include monitoring of adverse events, clinical laboratory tests, vital signs, and electrocardiographic measurements. Electrocardiographic data, including assessment of corrected QT interval, will be collected to support evaluation of cardiac safety in relation to exposure.
Because midomafetamine produces acute psychoactive effects during the dosing period, pharmacodynamic assessments-including subjective effects-will be collected to support interpretation of safety and tolerability findings. Pharmacokinetic assessments will also be performed to characterize systemic exposure.
This study is not designed to evaluate efficacy or treatment effectiveness for any disease or condition. Information collected from this study will be used to support the ongoing clinical development of midomafetamine.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究場所
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Kansas
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Overland Park、Kansas、アメリカ、66212
- Dr. Vince Clinical Research
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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:
- Healthy adult participants, 18 to 55 years of age
- Medically healthy as determined by medical history, physical examination, clinical laboratory testing, vital signs, and electrocardiogram
- Able and willing to comply with study procedures
Exclusion Criteria:
- History of clinically significant cardiovascular, neurological, or psychiatric disease
- Current or recent substance use disorder, or positive drug or alcohol screen at screening
- Prior exposure to midomafetamine exceeding a protocol-defined limit intended to minimize confounding of safety assessments (no more than 10% of participants may have lifetime prior exposure)
- Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with interpretation of study results
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：なし
- 介入モデル：順次割り当て
- 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：Experimental
Participants receive midomafetamine administered in sequential dose cohorts.
One cohort receives a targeted therapeutic dose administered in a split manner, and a subsequent cohort receives a supratherapeutic dose administered in a split manner.
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Midomafetamine HCl is administered orally to study participants.
他の名前：
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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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Incidence of Adverse Events
時間枠：From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)
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Assessment of adverse events and serious adverse events following administration of midomafetamine.
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From signing of informed consent through End of Study visit (Day 30 +/- 2 Days)
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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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Change from baseline in corrected QT interval (QTc) (ms)
時間枠：Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
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Corrected QT interval (QTc) will be assessed using 12-lead ECG data and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.
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Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
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Maximum plasma concentration (Cmax) of midomafetamine
時間枠：Predose (Day 1) through 48 hours postdose (Day 3)
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Plasma midomafetamine concentrations will be measured, and maximum plasma concentration (Cmax) will be derived from the concentration-time data.
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Predose (Day 1) through 48 hours postdose (Day 3)
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Time to maximum plasma concentration (Tmax) of midomafetamine
時間枠：Predose (Day 1) through 48 hours postdose (Day 3)
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Plasma midomafetamine concentrations will be measured, and time to maximum plasma concentration (Tmax) will be derived from the concentration-time data.
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Predose (Day 1) through 48 hours postdose (Day 3)
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Area under the plasma concentration-time curve (AUC0-24) of midomafetamine
時間枠：Predose (Day 1) through 24 hours postdose (Day 2)
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Plasma midomafetamine concentrations will be measured, and area under the concentration-time curve from time 0 to 24 hours (AUC0-24) will be derived from the concentration-time data.
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Predose (Day 1) through 24 hours postdose (Day 2)
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Change from baseline in subjective effects Visual Analog Scale (VAS) scores
時間枠：Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
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Subjective effects will be assessed using Visual Analog Scale (VAS) instruments and summarized as change from baseline at multiple postdose timepoints through 24 hours after dosing.
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Baseline (predose Day 1) and up to 24 hours postdose (Day 2)
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協力者と研究者
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
その他の研究ID番号
- RP-CL-P1-2501
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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