Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers
Sponsor:
Aptabio Therapeutics, Inc.
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | September 20, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | May 28, 2018 | ||
| Estimated Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
SAD study: incidence of treatment emergent adverse events[ Time Frame: Up to Day 8 ] Adverse events will be coded using Meddra. MAD study: incidence of treatment emergent adverse events[ Time Frame: Up to Day 17 ] Adverse events will be coded using Meddra. SAD study: number of clinically significant abnormal findings from biological tests[ Time Frame: Up to Day 8 ] Biological tests include hematology, biochemistry, hemostasis, hormonology, urinalysis, serology, and urine ionogram MAD study: number of clinically significant abnormal findings from biological[ Time Frame: Up to Day 17 ] Biological tests include hematology, biochemistry, hemostasis, hormonology, urinalysis, serology, and urine ionogram SAD study: number of clinically significant abnormal findings from physical exams[ Time Frame: Up to Day 8 ] Physical exams will be performed. MAD part: number of clinically significant abnormal findings from physical exams[ Time Frame: Up to Day 17 ] Physical exams will be performed. SAD study: number of clinically significant abnormal findings from vital sign (blood pressure and heart beat) assessments[ Time Frame: Up to Day 8 ] MAD study: number of clinically significant abnormal findings from vital sign[ Time Frame: Up to Day 17 ] SAD Study: number of clinically significant abnormal findings from concomitant medications[ Time Frame: Up to Day 8 ] MAD Study: number of clinically significant abnormal findings from concomitant medications[ Time Frame: Up to Day 17 ] SAD study: number of clinically significant abnormal findings from electrocardiogram[ Time Frame: Up to Day 8 ] MAD study: number of clinically significant abnormal findings from electrocardiogram[ Time Frame: Up to Day 17 ] Food Effect study: Cmax of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Maximum Observed Plasma Concentration of APX-115 will be assessed under fasting and fed conditions. Food Effect study: AUC of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Area Under the Plasma Concentration Time Curve of APX-115 will be assessed under fasting and fed conditions. Food Effect study: Tmax of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] The time at which the Tmax of APX-115 will be assessed under fasting and fed conditions. Food Effect study: half-life of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Half-life of APX-115 will be assessed under fasting and fed conditions. Food Effect study: Kel of APX-115 under fasting and fed conditions[ Time Frame: Up to 48 hours ] Elimination rate constant of APX-115 will be assessed under fasting and fed conditions. Drug Interaction Study: Cmax of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Maximum Observed Plasma Concentration of a metabolic probe will be assessed with and without a single dose of APX-115. Drug Interaction Study: Incidences of treatment emergent adverse events[ Time Frame: Up to 48 hours after administration of metabolic probe ] Adverse events will be coded using Meddra. Drug Interaction Study: tmax of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] First time to reach tmax (h) of a metabolic probe with and without a single dose of APX-115. Drug Interaction Study: Kel of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Elimination rate constant of a metabolic probe with and without a single dose of APX-115. Drug Interaction Study: t1/2 of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Plasma elimination half-life of a metabolic probe will be assessed with and without a single dose of APX-115. Drug Interaction Study: Volume of distribution of a metabolic probe with and without a single dose of APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Volume of distribution of a metabolic probe will be assessed with and without a single dose of APX-115 Drug Interaction Study: Clearance of a metabolic probe with and without a single dose of APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Clearance of a metabolic probe will be assessed with and without a single dose of APX-115. Drug Interaction Study: AUC of a metabolic probe with and without APX-115[ Time Frame: Up to 48 hours after administration of metabolic probe ] Area under the plasma concentration curve of a metabolic probe will be assessed with and without a single dose of APX-115. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers |
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| Official Title ICMJE | Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses or Multiple Ascending Doses of APX-115 in Healthy Male Volunteers. |
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| Brief Summary | This study aims to evaluate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of single ascending doses and multiple ascending doses of APX-115 in healthy males. This study also aims to evaluate the effect of food consumption on the pharmacokinetics of APX-115 and potential interaction between caffeine and APX-115 in healthy males. |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 1 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
88 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | December 31, 2018 | ||
| Estimated Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion: - Healthy male subject, aged between 18 and 45 years inclusive - Certified as healthy by a comprehensive clinical assessment - Normal dietary habits - Normal ECG recording on a 12-lead ECG - Signing a written informed consent prior to selection Exclusion: - Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious or ocular disease - Frequent headaches and / or migraine, recurrent nausea and / or vomiting - Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position - Blood donation (including in the frame of a clinical trial) within 2 months before administration - General anaesthesia within 3 months before administration - Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician - Inability to abstain from intensive muscular effort - No possibility of contact in case of emergency - Any drug intake (except paracetamol or contraception) during the last month prior to the first administration - History or presence of drug or alcohol abuse (alcohol consumption > 30 grams / day) - Excessive consumption of beverages with xanthine bases (> 4 cups or glasses / day) - Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests - Positive results of screening for drugs of abuse - Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development - Administrative or legal supervision | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | France | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | Yes | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Aptabio Therapeutics, Inc. | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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