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

March 7, 2019 updated by: Aptabio Therapeutics, Inc.

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Gières, France, 38610
        • Eurofins Optimed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
SAD: incidence of treatment emergent adverse events
Time Frame: Up to Day 8
Up to Day 8
SAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Time Frame: Up to Day 8
Up to Day 8
SAD: number of clinically significant abnormal findings from physical exam
Time Frame: Up to Day 8
Up to Day 8
SAD: number of clinically significant abnormal findings from electrocardiogram
Time Frame: Up to Day 8
Up to Day 8
SAD: number of clinically significant abnormal findings from biological tests
Time Frame: Up to Day 8
Up to Day 8
MAD: incidence of treatment emergent adverse events
Time Frame: Up to Day 17
Up to Day 17
MAD: number of clinically significant abnormal findings from vital signs (blood pressure, pulse)
Time Frame: Up to Day 17
Up to Day 17
MAD: number of clinically significant abnormal findings from physical exams
Time Frame: Up to Day 17
Up to Day 17
MAD: number of clinically significant abnormal findings from electrocardiogram
Time Frame: Up to Day 17
Up to Day 17
Food effect: peak serum concentration (Cmax) of APX-115 under fasting and fed conditions
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect: time to reach the Cmax (Tmax) of APX-115 under fasting and fed conditions
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect: area under the curve (AUC) of APX-115 under fasting and fed conditions
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect: elimination rate constant (Kel) of APX-115 under fasting and fed conditions
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect: ratio AUCfed/AUCfasted
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: peak serum concentration (Cmax) of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: Time to reach the Cmax (tmax) of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction study: Area under the Curve (AUC) of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: elimination rate constant (Kel) of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: half-life (t1/2) of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: volume of distribution (Vd/f) of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: clearance of a metabolic probe or APX-115
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Drug interaction: Incidences of treatment emergent adverse events
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
SAD: time to reach Cmax (Tmax) of APX-115
Time Frame: Up to Day 5
Up to Day 5
SAD: peak serum concentration (Cmax) of APX-115
Time Frame: Up to Day 5
Up to Day 5
SAD: lowest plasma concentration before next dosing (Ctrough)
Time Frame: Up to Day 5
Up to Day 5
SAD: Area Under the Curve (AUC) of APX-115
Time Frame: Up to Day 5
Up to Day 5
SAD: volume of distribution (Vd/F) of APX-115
Time Frame: Up to Day 5
Up to Day 5
SAD: clearance (CL/F) of APX-115
Time Frame: Up to Day 5
Up to Day 5
MAD: peak serum concentration (Cmax) of APX-115
Time Frame: Up to Day 11
Up to Day 11
MAD: time to reach the Cmax (Tmax) of APX-115
Time Frame: Up to Day 11
Up to Day 11
MAD: Area Under the Curve (AUC) of APX-115
Time Frame: Up to Day 11
Up to Day 11
MAD: lowest plasma concentration of APX-115 before next dosing (Ctrough)
Time Frame: Up to Day 11
Up to Day 11
MAD: volume of distribution (Vd/F) of APX-115
Time Frame: Up to Day 11
Up to Day 11
MAD: Clearance (CL/F) of APX-115
Time Frame: Up to Day 11
Up to Day 11
MAD: accumulation ratio
Time Frame: Up to Day 11
Up to Day 11
Food effect & drug interaction: incidence of treatment emergent adverse events
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from vital signs (blood pressure and pulse)
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from physical exam
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from electrocardiogram
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose
Food effect & drug interaction: number of clinically significant findings from biological tests
Time Frame: Up to Day 4 post-dose
Up to Day 4 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aptabio Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OP101817.APT
  • 2017-004252-30 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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