Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Stable Angina

Keywords

PharmacokineticsBioavailabilitySafetyTolerabilityFastingFed

Outcome Measures

Primary Outcomes (6)

Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fasting conditions
Total nicorandil plasma concentration over 24 hours under fasting conditions
24 hours
Area under the curve over 24 hours [AUC0-24h)] of nicorandil under fed conditions
Total nicorandil plasma concentration over 24 hours under fed conditions
24 hours
Maximum Plasma Concentration [Cmax] of nicorandil under fasting conditions
Peak plasma concentration under fasting conditions in mcg/ml
24 hours
Maximum Plasma Concentration [Cmax] of nicorandil under fed conditions
Peak plasma concentration under fed conditions in mcg/ml
24 hours

Secondary Outcomes (2)

Treatment-emergent adverse events [TEAE] under fasting conditions
24 hours
Treatment-emergent adverse events [TEAE] under fed conditions
24 hours

Study Arms (2)

Arm A: fasting

EXPERIMENTAL

AUX-001 40mg QD

Drug: AUX-001 40mg once-daily

Arm B: fed

EXPERIMENTAL

AUX-001 40mg QD

Drug: AUX-001 40mg once-daily

Interventions

AUX-001 40mg once-dailyDrug

AUX-001 (extended-release nicorandil) 40mg QD (once-daily)

Also known as: Food effect

Arm A: fastingArm B: fed

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Free written informed consent signed and dated prior to any procedure required by the study.
Male or female subject between 18 and 55years, inclusive, at the time of signing the informed consent.

Sponsors & Collaborators

Auxilius Pharma sp.z.o.o.
Industrylead

Study Sites (1)

BlueClinical

Porto, 4250-449, Portugal

MeSH Terms

Conditions

Angina, StableFastingLecithin Cholesterol Acyltransferase Deficiency

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

Marlene Fonseca, MD
Blueclinical, Ltd.
PRINCIPAL INVESTIGATOR
Uwe P Tigör, MD
Auxilius Pharma
STUDY DIRECTOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 20, 2023

First Posted

February 8, 2024

Study Start

November 27, 2023

Actual (reported)

Pharmacokinetics of AUX-001 40mg Once-daily in Healthy Subjects Under Fasting and Fed Conditions

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (2)

Study Arms (2)

Arm A: fasting

Arm B: fed

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (2)

Study Arms (2)

Arm A: fasting

Arm B: fed

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations