Human Mass Balance Study of [14C] Ontunisertib in Healthy Volunteers
An Open-label, Two-part Trial to Assess the Mass-balance Recovery, Metabolite Profile, Metabolite Identification and Absolute Bioavailability of [14C] Ontunisertib in Healthy Male Participants
This is an open, two-part study in healthy male volunteers, aged 30-65 years.
This trial aims to understand how the human body absorbs, distributes, metabolizes and eliminates ontunisertib after a single oral dose of radiolabelled test medicine ([14C]ontunisertib) and determine the routes and rates of elimination of the test medicine.
調査の概要
詳細な説明
This is an open, two-part study in healthy male volunteers, aged 30-65 years with the trial duration of approximately 7 weeks.
In Part 1 of this study, healthy volunteers will be given a dose of test medicine orally followed by an intravenous injection of a very small dose of radiolabelled test medicine that contains a tiny amount of radioactivity (called carbon-14) so that the test medicine can be traced in the blood.
In Part 2, single doses of test medicine will be administered orally to find out how the body breaks down and gets rid of the test medicine. The test medicine will be 'radiolabelled' - it will contain a small amount of radioactivity (Carbon-14) - so that it can be traced in the body.
Participants will take part in both study parts and will remain resident in the clinic for up to 10 days after their final dose of Investigation Medicinal Product (IMP). After the participants have left the clinic, they may have to collect their urine and faeces at home until mass balance criteria has been met.
Over a period of at least 8 days in Part 1 and 10 days in Part 2, many blood samples will be taken, and volunteers will collect all their urine and faeces so that the amount of test medicine and its breakdown products can be measured/analysed.
A blood sample will be taken from volunteers between admission and first dose for pharmacogenetic testing.
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：Agomab Clinical Operations
- 電話番号：0032 3318 91 70
- メール：clinicalstudies@agomab.com
研究場所
-
-
-
Nottingham、イギリス、NG11 6JS
- 募集
- Quotient Sciences Limited
-
-
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 Criteria:
- Males aged 30 to 65 years inclusive at the time of signing informed consent
- Must agree to the use of an adequate method of contraception for up to 93 days post-final dose
- Healthy male participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs, 12-lead ECG, and laboratory safety tests without any clinically significant abnormalities.
- Body mass index of 18.0 to 29.9 kg/m2
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- History of clinically significant renal, hepatic, respiratory, particularly GI disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome, and neurological or psychiatric disorder
- History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
- Clinically significant abnormal clinical chemistry, hematology, coagulation or urinalysis as judged by the investigator at screening.
- Radiation exposure, including that from the present trial, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the trial
- Participants who have been administered IMP in an ADME trial or any trial involving administration of 14C radioactivity in the last 12 months
- Male participants with pregnant or lactating partners
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：他の
- 割り当て：非ランダム化
- 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 |
|---|---|
|
実験的：Ontunisertib
Participants will receive single oral dose of ontunisertib
|
Oral capsule
他の名前：
|
|
実験的：[14C]ontunisertib solution for infusion
Participants will receive single IV dose of [14C]ontunisertib
|
IV infusion
Oral capsule
|
|
実験的：[14C]ontunisertib
Participants will receive single oral dose of [14C]ontunisertib
|
IV infusion
Oral capsule
|
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 |
|---|---|---|
|
Absolute bioavailability of ontunisertib following oral and IV administration
時間枠：Through study completion, an average of 8 days
|
Part 1: To determine the absolute oral bioavailability of ontunisertib
|
Through study completion, an average of 8 days
|
|
Cumulative amount of total radioactivity excreted in urine and feces
時間枠：Through study completion, an average of 10 days
|
Part 2: To determine the mass balance recovery after a single oral dose of [14C]ontunisertib
|
Through study completion, an average of 10 days
|
|
Chemical structure of each metabolite accounting for ≥10% of circulating total radioactivity and Metabolite profiling accounting for >80% of total radioactivity recovered in urine and/or feces
時間枠：Through study completion, an average of 10 days
|
Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of [14C]ontunisertib
|
Through study completion, an average of 10 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
PK parameter (AUClast)
時間枠：Through study completion, an average of 8 days
|
Part 1: To characterize the IV PK (AUClast) of [14C]ontunisertib and total radioactivity in plasma
|
Through study completion, an average of 8 days
|
|
Cumulative amount of total radioactivity excreted in urine and feces following IV administration
時間枠：Through study completion, an average of 8 days
|
Part 1: To determine the mass balance recovery after a single IV dose of [14C]ontunisertib
|
Through study completion, an average of 8 days
|
|
PK parameter (AUClast)
時間枠：Through study completion, an average of 18 days
|
Part 1 and Part 2: To characterize the plasma PK (AUClast) of ontunisertib and metabolites and total radioactivity (Part 2 only) following a single oral dose
|
Through study completion, an average of 18 days
|
|
Whole blood-to-plasma concentration ratios for total radioactivity
時間枠：Through study completion, an average of 10 days
|
Part 2: To evaluate the extent of distribution of total radioactivity into blood cells
|
Through study completion, an average of 10 days
|
|
Number of participants with adverse events (AEs)
時間枠：Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Number of participants with abnormal physical examinations
時間枠：Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Number of participants with abnormal vital signs
時間枠：Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Number of participants with abnormal ECGs parameters
時間枠：Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Number of participants with abnormal clinical laboratory safety tests
時間枠：Through study completion, an average of 18 days
|
Part 1 and Part 2: To assess the safety and tolerability of ontunisertib
|
Through study completion, an average of 18 days
|
|
Chemical structure analysis of metabolites accounting for ≥10%
時間枠：Through study completion, an average of 8 days
|
Part 1: To characterize the metabolites profile in plasma following an IV dose of [14C]ontunisertib
|
Through study completion, an average of 8 days
|
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：Silke Hüttner, MD、Agomab Therapeutics
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
- AGMB129-01-CL-105
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?
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。