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

Phase 1

Completed

• Conditions: Safety; Healthy
• Interventions: Other: Metabolic probe with or without APX-115

• Registration Number: NCT03694041
• Lead Sponsor: Aptabio Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-28
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Status Verified: 2019-03
• Primary Completion: 2019-03-06
• Study Completion: 2019-03-06
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Interaction - metabolic probe	Metabolic probe with or without APX-115	Experimental: metabolic probe

Primary Outcome Measures

Name	Time	Method
SAD: incidence of treatment emergent adverse events	Up to Day 8
SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)	Up to Day 8
SAD: number of clinically significant abnormal findings from physical exam	Up to Day 8
SAD: number of clinically significant abnormal findings from electrocardiogram	Up to Day 8
SAD: number of clinically significant abnormal findings from biological tests	Up to Day 8
MAD: incidence of treatment emergent adverse events	Up to Day 17
MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)	Up to Day 17
MAD: number of clinically significant abnormal findings from physical exams	Up to Day 17
MAD: number of clinically significant abnormal findings from electrocardiogram	Up to Day 17
Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions	Up to Day 4 post-dose
Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions	Up to Day 4 post-dose
Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115	Up to Day 4 post-dose
Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115	Up to Day 4 post-dose
Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115	Up to Day 4 post-dose
Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions	Up to Day 4 post-dose
Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions	Up to Day 4 post-dose
Food effect: ratio AUCfed/AUCfasted	Up to Day 4 post-dose
Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115	Up to Day 4 post-dose
Drug interaction: half-life (t1/2) of a metabolic probe or APX-115	Up to Day 4 post-dose
Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115	Up to Day 4 post-dose
Drug interaction: clearance of a metabolic probe or APX-115	Up to Day 4 post-dose
Drug interaction: Incidences of treatment emergent adverse events	Up to Day 4 post-dose

Secondary Outcome Measures

Name	Time	Method
SAD: time to reach Cmax (Tmax) of APX-115	Up to Day 5
SAD: peak serum concentration (Cmax) of APX-115	Up to Day 5
SAD: lowest plasma concentration before next dosing (Ctrough)	Up to Day 5
SAD: Area Under the Curve (AUC) of APX-115	Up to Day 5
SAD: volume of distribution (Vd/F) of APX-115	Up to Day 5
SAD: clearance (CL/F) of APX-115	Up to Day 5
MAD: peak serum concentration (Cmax) of APX-115	Up to Day 11
MAD: time to reach the Cmax (Tmax) of APX-115	Up to Day 11
MAD: Area Under the Curve (AUC) of APX-115	Up to Day 11
MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough)	Up to Day 11
MAD: volume of distribution (Vd/F) of APX-115	Up to Day 11
MAD: Clearance (CL/F) of APX-115	Up to Day 11
MAD: accumulation ratio	Up to Day 11
Food effect & drug interaction: incidence of treatment emergent adverse events	Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse)	Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from physical exam	Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from electrocardiogram	Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from biological tests	Up to Day 4 post-dose

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gières, France