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Safety, Tolerability, PK and PD of SAD or MAD of APX-115 in Healthy Male Volunteers

Sponsor
Aptabio Therapeutics, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT03694041
Collaborator
(none)
88
Enrollment
1
Location
7
Arms
9.3
Actual Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SAD: APX-115
  • Drug: SAD: Placebo
  • Drug: MAD: APX-115
  • Drug: MAD: Placebo
  • Other: Food effect: fasted and fed
  • Other: Metabolic probe with or without APX-115
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel design for SAD and MAD studies Crossover design for Food and Drug interaction studiesParallel design for SAD and MAD studies Crossover design for Food and Drug interaction studies
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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.
Actual Study Start Date :
May 28, 2018
Actual Primary Completion Date :
Mar 6, 2019
Actual Study Completion Date :
Mar 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAD: APX-115

Experimental: APX-115 SAD group

Drug: SAD: APX-115
Drug: APX-115 SAD APX-115 SAD for 1day
Placebo Comparator: SAD: Placebo

Experimental: Placebo group

Drug: SAD: Placebo
Drug: Placebo Placebo for 1day
Experimental: MAD: APX-115

Experimental: APX-115 MAD group

Drug: MAD: APX-115
Drug: APX-115 MAD APX-115 MAD repeatedly administered.
Placebo Comparator: MAD: Placebo

Experimental: Placebo group

Drug: MAD: Placebo
Matching study drug will be repeatedly administered.
Active Comparator: Food effect - Fasting condition

Experimental: APX-115 under fasting condition

Other: Food effect: fasted and fed
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
Active Comparator: Food effect - fed condition

Experimental: APX-115 under fed condition

Other: Food effect: fasted and fed
A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
Placebo Comparator: Drug Interaction - metabolic probe

Experimental: metabolic probe

Other: Metabolic probe with or without APX-115
A metabolic probe will be administered with and without APX-115.

Outcome Measures

Primary Outcome Measures

  1. SAD: incidence of treatment emergent adverse events [Up to Day 8]

  2. SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse) [Up to Day 8]

  3. SAD: number of clinically significant abnormal findings from physical exam [Up to Day 8]

  4. SAD: number of clinically significant abnormal findings from electrocardiogram [Up to Day 8]

  5. SAD: number of clinically significant abnormal findings from biological tests [Up to Day 8]

  6. MAD: incidence of treatment emergent adverse events [Up to Day 17]

  7. MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse) [Up to Day 17]

  8. MAD: number of clinically significant abnormal findings from physical exams [Up to Day 17]

  9. MAD: number of clinically significant abnormal findings from electrocardiogram [Up to Day 17]

  10. Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions [Up to Day 4 post-dose]

  11. Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions [Up to Day 4 post-dose]

  12. Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions [Up to Day 4 post-dose]

  13. Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions [Up to Day 4 post-dose]

  14. Food effect: ratio AUCfed/AUCfasted [Up to Day 4 post-dose]

  15. Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  16. Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  17. Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  18. Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  19. Drug interaction: half-life (t1/2) of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  20. Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  21. Drug interaction: clearance of a metabolic probe or APX-115 [Up to Day 4 post-dose]

  22. Drug interaction: Incidences of treatment emergent adverse events [Up to Day 4 post-dose]

Secondary Outcome Measures

  1. SAD: time to reach Cmax (Tmax) of APX-115 [Up to Day 5]

  2. SAD: peak serum concentration (Cmax) of APX-115 [Up to Day 5]

  3. SAD: lowest plasma concentration before next dosing (Ctrough) [Up to Day 5]

  4. SAD: Area Under the Curve (AUC) of APX-115 [Up to Day 5]

  5. SAD: volume of distribution (Vd/F) of APX-115 [Up to Day 5]

  6. SAD: clearance (CL/F) of APX-115 [Up to Day 5]

  7. MAD: peak serum concentration (Cmax) of APX-115 [Up to Day 11]

  8. MAD: time to reach the Cmax (Tmax) of APX-115 [Up to Day 11]

  9. MAD: Area Under the Curve (AUC) of APX-115 [Up to Day 11]

  10. MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough) [Up to Day 11]

  11. MAD: volume of distribution (Vd/F) of APX-115 [Up to Day 11]

  12. MAD: Clearance (CL/F) of APX-115 [Up to Day 11]

  13. MAD: accumulation ratio [Up to Day 11]

  14. Food effect & drug interaction: incidence of treatment emergent adverse events [Up to Day 4 post-dose]

  15. Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse) [Up to Day 4 post-dose]

  16. Food effect & drug interaction: number of clinically significant findings from physical exam [Up to Day 4 post-dose]

  17. Food effect & drug interaction: number of clinically significant findings from electrocardiogram [Up to Day 4 post-dose]

  18. Food effect & drug interaction: number of clinically significant findings from biological tests [Up to Day 4 post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eurofins Optimed Gières France 38610

Sponsors and Collaborators

  • Aptabio Therapeutics, Inc.

Investigators

  • Principal Investigator: Yves Donazzolo, MD, Eurofins Optimed

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aptabio Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03694041
Other Study ID Numbers:
  • OP101817.APT
  • 2017-004252-30
First Posted:
Oct 3, 2018
Last Update Posted:
Mar 11, 2019
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Mar 11, 2019