E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007050 |
E.1.2 | Term | Cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To characterize the absorption, metabolism, and excretion (AME), and mass balance of a single oral dose of 120 mg MGCD516 malate salt (therapeutic dose) containing XX MBq of [14C]-labeled MGCD516 in healthy male subjects |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of MGCD516 following a single oral dose of 120 mg MGCD516 malate salt |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Gender: male. 2. Age: 18 to 55 years, inclusive, at screening. 3. Body mass index (BMI):18.0 to 30.0 kg/m2. 4. Weight: >50 kg. 5. Status: healthy subjects. Further criteria apply |
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E.4 | Principal exclusion criteria |
1. Employee of PRA or the Sponsor. 2. Significant history or clinical manifestation of any major system disorder, as determined by the Investigator (or designee). 3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). 4. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs. 5. Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines. Further criteria apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
MGCD515 in plasma: Cmax, tmax, kel, t1/2, AUC0-t, AUC0-inf, AUC0-168, CL/F, and Vz/F
MGCD515 in urine: Aeurine, feurine, and CLR
Total radioactivity in plasma and whole blood: Cmax, tmax, kel, t1/2, AUC0-t, AUC0-inf, AUC0-168, and whole blood/plasma ratio
Total radioactivity excretion in urine and feces: Aeurine, feurine, Aefeces, fefeces, Aetotal, and fetotal
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• AEs • Clinical laboratory • Vital signs • ECG • Physical examination
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Mass balance, Metabolic Profile |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Mass balance, metabolic profile |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |