AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects

April 29, 2020 updated by: Axalbion SA

A Phase 1 Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Twice Daily Administration of AX-8 Tablets in Healthy Volunteers in a Single-Centre

The main purpose of the study is to see how safe the study drug AX-8 is and how well it is tolerated when administered at different dose levels in healthy participants.

The study will also investigate pharmacokinetics (PK), i.e how the study drug is taken up, metabolized (broken down) and eliminated.

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Detailed Description

The primary objective of the study is to investigate the safety and tolerability of ascending AX-8 oral doses, i.e. orally disintegrating tablets (ODTs), administrated twice for one day (Day 1) in healthy participants.

The secondary objectives are to investigate the pharmacokinetic (PK) profile and the subjective sensory attributes (e.g. basic tastes, palatability, cooling) of ascending AX-8 oral doses (ODTs), administered twice for one day in healthy participants.

The study consists of two parts.

Part 1

The first part of the study (Part 1) is an ascending dose, open-label, single center study in healthy participants. Part 1 will consist of a Screening Period (Days -28 to -1) to assess eligibility to participate in the study, 4 Treatment Periods (Day 1 to Day 2; one overnight stay for each treatment period) with a minimum washout period of 48 hours between doses (however a longer period will be required for dose escalation / safety review decisions, as required) and a Follow-Up Visit 7 to 14 days post last dose.

During each treatment period, participants will be admitted to the study center on the morning of Day 1 and discharged from the study center on the morning of Day 2 (i.e. after the pre-discharge procedures have been performed). Participants will attend a Follow-Up Visit (or Early Withdrawal Visit as applicable) to complete the study.

The end of the study will be the date of the last study visit for the last participant in the study (LPLV).

It is planned to include 10 eligible participants into Part 1 of the study to receive AX-8 ODTs administered orally which will be dissolved on the tongue (oromucosal route of administration). Participants will receive doses of AX-8 ODTs up to 80 mg/day, administered split over 2 dosing time points (i.e. 0 hour and + 8 hours), as follows:

Treatment Period 1: 2 x 5 mg tablets, 10 mg total;
Treatment Period 2: 2 x 10 mg tablets, 20 mg total;
Treatment Period 3: 2 x 20 mg tablets, 40 mg total;
Treatment Period 4: 2 x 40 mg tablets, 80 mg total.

Dosing in each sequential treatment period will be staggered; after the first 2 participants (i.e. sentinel group) are dosed there will be at least a 24-hour observation period from the morning dose (0 hour) before the remaining 8 participants are dosed. The remaining participants will be dosed if the sentinel group shows no clinically significant safety or tolerability concerns (including available safety electrocardiograms [ECGs], vital signs measurements, physical examinations and review of any adverse events [AEs]) at the discretion of the PI. Any clinically significant findings from the sentinel group in the opinion of the PI will be discussed with the Sponsor prior to dosing of the remaining 8 participants.

Dose escalation will be based on safety and tolerability data from each treatment period. In addition, available PK data from Treatment Period 1 (5 mg; twice daily) and Treatment Period 2 (10 mg; twice daily) will be used to support dose escalation decisions for Treatment Period 3 (20 mg; twice daily) and Treatment Period 4 (40 mg; twice daily).

Escalation to the next higher dose level (i.e. next sequential treatment period) will not take place until the site's PI and the Sponsor have determined that adequate safety and tolerability data from the previous treatment period has been demonstrated to permit proceeding to the next sequential treatment period (i.e. higher dose level). The minimum data package required for dose escalation decisions will include safety and tolerability data through Day 2 in a minimum of 6 participants (including available safety ECGs, vital signs measurements, physical examinations, clinical laboratory tests and review of any adverse events). Safety reports will be produced summarizing the safety data of the participants. The justification for selection of the dose will be prepared by the investigator for the proposed dose escalation and documented in the dose escalation meeting minutes.

Additional participants may be enrolled if it is deemed appropriate by the site's PI and the Sponsor to repeat a dose level or to study an intermediate dose level (lower than those planned). Repetition of a dose level will not be permitted for dose levels that met any of the stopping rules.

Part 2

The first part of the study (Part 1) has been completed, i.e. 10 participants were recruited and received AX-8 (10 mg to 80 mg/day) over 4 treatment periods (in a dose escalation regimen) and have attended their follow-up visits. The interim analysis of the study data from Part 1 has concluded that tablet dissolution time was too long, affecting systemic exposure to AX-8, probably due to the instructions for administration. Consequently, it was decided to re-evaluate the 5 mg and 40 mg AX-8 tablets with other administration instructions.

It is planned that 10 participants will be enrolled into Part 2 of the study to receive a total dose of 45 mg split into two doses on Day 1 (Dose 1 (5 mg): +0 h, Dose 2 (40 mg): + 8 h).

Part 2 will consist of a Screening Period (Days -28 to -1) to assess eligibility to participate in the study, 1 Treatment Period (Day 1 to Day 2; one overnight stay) and a Follow-Up Visit 7 to 14 days post last dose. There will be no dose escalation decisions nor dose staggering of participants as the doses to be administered in Part 2 are lower than the highest dose level administered in Part 1.

For Part 1 and Part 2; blood samples will be taken pre and post each dose to measure plasma concentrations of AX-8, despropyl AX-8 (metabolite C, MetC) and potentially other AX-8 metabolites and compounds. Subjective assessments to characterise the sensory attributes of the AX-8 ODTs (e.g. feeling factors and taste) will be performed pre and post each dose. Safety assessments will be performed throughout the study and will include monitoring adverse events (AEs), physical examinations, vital signs, 12-lead ECGs, and clinical laboratory tests.

The duration of the study will be approximately 65 days for subjects enrolled in Part 1 and approximately 44 days for subjects enrolled in Part 2; however, the actual duration will depend on the length of the screening period and the washout periods (as appropriate).

Study Type

Interventional

Enrollment (Actual)

Phase

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

United Kingdom
- - Manchester, United Kingdom, M23 9QZ
    - Medicines Evaluation Unit (MEU) Ltd

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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Healthy male and female volunteers aged ≥ 18 and ≤ 55 years at the time of informed consent
Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly effective birth control method
Female subjects (regardless of childbearing potential) must agree not to donate ova/oocytes during the study from the first dosing day and until 30 days after the last dose
Male subjects with female partners of childbearing potential must be vasectomised with documented medical assessment of the surgical success, or use highly effective contraception together with their female partner(s)
Male subjects must agree not to donate sperm during the study from the first dosing day and until 90 days after last dose
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
Have provided written informed consent
Are willing and able to comply with all aspects of the protocol
Normal electrocardiogram (ECG) and vital signs (or abnormalities which the clinical Investigator considers the deviation to be irrelevant for the purpose of the study) during screening and prior to first dose
Laboratory values within the normal range (or the clinical Investigator considers the deviation to be irrelevant for the purpose of the study) during screening
Findings within the range of clinical acceptability in medical history and physical examination (or the clinical Investigator considers the deviation to be irrelevant for the purpose of the study)

Exclusion Criteria:

Prior treatment with AX-8
Hypersensitivity or intolerance to transient receptor potential melastatin subfamily, member 8 (TRPM8) agonists (e.g. menthol, menthol-derivatives, eucalyptol) or any of the excipients of the AX-8 tablets
Current smoker or individuals who have given up smoking for less than 12 months or ex smoker with > 10 pack-years
History of upper or lower respiratory tract infection within 4 weeks prior to screening or prior to first dose.
Requiring concomitant therapy with prohibited medications
Treatment with biologic therapies within 8 weeks or 5 half-lives, whichever is longer, prior to screening
Treatment with any investigational therapy within 4 weeks prior to screening
Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > the upper limit of normal (ULN) during screening
Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or antibodies against human immunodeficiency virus 1 or 2 (HIV-1 and HIV-2 Abs) during screening
Positive tests for drugs of abuse or alcohol breath test at screening or prior to first dose
History of malignancy, with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, within 5 years prior to screening
History of a major psychiatric condition (including major depressive disorder, bipolar disorder, or schizophrenia), suicidal ideation, or suicide attempt
Presence of any medical condition or disability that, in the Investigator's opinion, could interfere with the assessment of safety or efficacy in this study or compromise the safety of the subject
History or presence of alcoholism or drug abuse within the past 2 years prior to screening
Females who are currently pregnant, breastfeeding or lactating, or who have a positive pregnancy test at screening or prior to first dose
Male subjects with a pregnant, breastfeeding or lactating partner or a partner who is planning to become pregnant during the study or within 90 days after the last dose
Donation of blood (≥ 400 mL) or plasma, or significant blood loss within 56 days prior to screening

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: Non-Randomized
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 arm Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg, 10 mg, 20 mg or 40 mg AX-8 twice daily (8 hours apart, i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of treatment periods 1, 2, 3 or 4, respectively.	Drug: AX-8 Part 1 5, 10, 20, and 40 mg AX-8 orally disintegrating tablets (ODTs), up to 80 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved on the back of the tongue while the subject is in a sitting position. The subjects will be instructed not to suck, chew or swallow the tablet, i.e. to allow it to dissolve on the back of the tongue without any further intervention.
Experimental: Part 2 arm Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg AX-8 and one ODT with 40 mg AX-8 8 hours later (i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of the treatment period.	Drug: AX-8 Part 2 5 and 40 mg AX-8 orally disintegrating tablets (ODTs), 45 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved in the mouth while the subject is in a sitting position. The subjects will be instructed to actively move the tablet around in their mouth (i.e. active oral manipulation of the tablet) until it is fully dissolved.

Participant Group / Arm

Intervention / Treatment

Experimental: Part 1 arm

Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg, 10 mg, 20 mg or 40 mg AX-8 twice daily (8 hours apart, i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of treatment periods 1, 2, 3 or 4, respectively.

Drug: AX-8 Part 1

5, 10, 20, and 40 mg AX-8 orally disintegrating tablets (ODTs), up to 80 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved on the back of the tongue while the subject is in a sitting position. The subjects will be instructed not to suck, chew or swallow the tablet, i.e. to allow it to dissolve on the back of the tongue without any further intervention.

Experimental: Part 2 arm

Ten healthy participants will receive one orally disintegrating tablet (ODT) with 5 mg AX-8 and one ODT with 40 mg AX-8 8 hours later (i.e. at 0 hour and +8 hours), during the treatment day (Day 1) of the treatment period.

Drug: AX-8 Part 2

5 and 40 mg AX-8 orally disintegrating tablets (ODTs), 45 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved in the mouth while the subject is in a sitting position. The subjects will be instructed to actively move the tablet around in their mouth (i.e. active oral manipulation of the tablet) until it is fully dissolved.

What is the study measuring?

Primary Outcome Measures

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Axalbion SA

Investigators

Principal Investigator: Dave Singh, MD, Medicines Evaluation Unit (MEU) Ltd

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)

September 9, 2019

Primary Completion (Actual)

February 25, 2020

Study Completion (Actual)

March 4, 2020

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

AX8-002
2019-002294-57 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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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Outcome Measure	Measure Description	Time Frame
Area under the plasma concentration-time curve from the first time point [t=0] to the time point of the last measured concentration [tlast] (AUC0-tlast) of AX-8 and its metabolite (ng.h/mL) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Maximum plasma concentration (Cmax) of AX-8 and its metabolite (ng/mL) for Dose 1 (Cmax1) and Dose 2 (Cmax2) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Percentage area extrapolated to infinity (%AUCx) of AX-8 and its metabolite (ng.h/mL) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Residual area, extrapolated area expressed as fraction of AUC(0-∞) (AUC(t-∞)) of AX-8 and its metabolite (ng.h/mL) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Time of maximum plasma concentration (tmax) of AX-8 and its metabolite for Dose 1 (tmax1) and Dose 2 (tmax2) (h) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Elimination half-life (t½) of AX-8 and its metabolite for Dose 2 only (h) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Elimination rate constant (λz) of AX-8 and its metabolite for Dose 2 only (1/h) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Dose normalized AUC0-tlast: AUC0-tlast / (Dose 1 + Dose 2) of AX-8 and its metabolite (ng.h/mL/mg) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the first time point to the 6th hour (AUC0-6) of AX-8 and its metabolite (ng.h/mL) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the 8th to 14th hour (AUC8-14) of AX-8 and its metabolite (ng.h/mL) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Area under the plasma concentration-time curve from the first time point to the 24th hour (AUC0-24) of AX-8 and its metabolite (ng.h/mL) Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Accumulation based on AUC (RAUC): AUC0-6 / AUC8-14 of AX-8 and its metabolite Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Accumulation based on Cmax (RCmax): Cmax2 / Cmax1 of AX-8 and its metabolite Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
Dose normalized Cmax: Cmax1 / Dose 1 of AX-8 and its metabolite Time Frame: Part 1 and Part 2: Treatment periods (Days 1 and 2).		Part 1 and Part 2: Treatment periods (Days 1 and 2).
AX-8 ODT cooling VAS (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity of cooling scored with a 100-mm visual analog scale (VAS) as part of a cooling questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Sweet taste (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity of sweet taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Sour taste (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity of sour taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Salty taste (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity of salty taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Bitter taste (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity of bitter taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Umami taste (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity of umami taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Other taste (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Intensity and nature of other taste of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).
AX8-ODT taste and palatability VAS - Palatability (mm) Time Frame: Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).	Palatability of the AX-8 ODTs scored with 100-mm visual analog scales (VAS) as part of a taste and palatability questionnaire.	Part 1 and Part 2: Treatment periods (Day 1, i.e. treatment day).

AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects

A Phase 1 Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Twice Daily Administration of AX-8 Tablets in Healthy Volunteers in a Single-Centre

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Healthy

Clinical Trials on AX-8 Part 1

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