CompletedPhase 1

Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on Systemic Exposure of Midazolam and Digoxin

Sweden37 participantsStarted 2023-10-23

Plain-language summary

The aim of this trial is to assess the potential key drug-drug interactions with EP395 in the clinical setting.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to understand the information on the nature, the scope, and the relevance of the trial, and to provide voluntary, written informed consent to participate in the trial before any trial-related procedures.
✓. Healthy male or female participant aged 18 to 55 years, inclusive.
✓. Body mass index ≥ 19.0 and ≤ 33.0 kg/m2 at the time of the screening visit.
✓. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
✓. Non-smoker, or former smoker with \<10 pack years who stopped smoking (including e-cigarettes) at least 6 months before the screening visit.
✓. Women of childbearing potential (WOCBP) must:
✓. have a negative pregnancy test (blood) at the screening visit and (urine) Day 1.
✓. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during trial participation and until 90 days after the last IMP intake.

Exclusion criteria

✕. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results, or the participant's ability to participate in the trial.
✕. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
✕. Presence or history of lung disease, e.g., asthma, chronic obstructive pulmonary disease.
✕. Presence or history of significant gastrointestinal medical condition that could lead to abnormal absorption.
✕. History of or active tuberculosis at the time of the screening visit based on participant anamnesis. Participants who have been living together with another person with active tuberculosis at any time over the past 10 years will also be excluded.
✕. Clinically significant abnormality on 12-lead ECG at the screening visit or Day 1 pre-dose, including prolonged QTcF (\>450 msec men or \>470 msec women) or PR interval \>210 msec.
✕. Abnormal renal function at the time of the screening visit:
✕. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 x ULN at the time of the screening visit.

What they're measuring

Part A: PK parameters of EP395 - AUC0-24

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - AUC0-inf

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - AUC%extrap

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - CL/F

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - Cmax

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - Tmax

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - T1/2

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - Vz/F

Timeframe: Days 1 to 6 and Day 14 to 19

Trial details

NCT IDNCT06118684

SponsorEpiEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-02

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease Exacerbation trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Willing and able to understand the information on the nature, the scope, and the relevance of the trial, and to provide voluntary, written informed consent to participate in the trial before any trial-related procedures.
✓. Healthy male or female participant aged 18 to 55 years, inclusive.
✓. Body mass index ≥ 19.0 and ≤ 33.0 kg/m2 at the time of the screening visit.
✓. Medically healthy participant without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
✓. Non-smoker, or former smoker with \<10 pack years who stopped smoking (including e-cigarettes) at least 6 months before the screening visit.
✓. Women of childbearing potential (WOCBP) must:
✓. have a negative pregnancy test (blood) at the screening visit and (urine) Day 1.
✓. agree to use, and be able to comply with, highly effective measures of contraceptive control (failure rate less than 1% per year when used consistently and correctly) without interruption, during trial participation and until 90 days after the last IMP intake.

Exclusion criteria

✕. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the results, or the participant's ability to participate in the trial.
✕. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the (first) administration of IMP.
✕. Presence or history of lung disease, e.g., asthma, chronic obstructive pulmonary disease.
✕. Presence or history of significant gastrointestinal medical condition that could lead to abnormal absorption.
✕. History of or active tuberculosis at the time of the screening visit based on participant anamnesis. Participants who have been living together with another person with active tuberculosis at any time over the past 10 years will also be excluded.
✕. Clinically significant abnormality on 12-lead ECG at the screening visit or Day 1 pre-dose, including prolonged QTcF (\>450 msec men or \>470 msec women) or PR interval \>210 msec.
✕. Abnormal renal function at the time of the screening visit:
✕. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 x ULN at the time of the screening visit.

What they're measuring

Part A: PK parameters of EP395 - AUC0-24

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - AUC0-inf

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - AUC%extrap

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - CL/F

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - Cmax

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - Tmax

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - T1/2

Timeframe: Days 1 to 6 and Day 14 to 19

Part A: PK parameters of EP395 - Vz/F

Timeframe: Days 1 to 6 and Day 14 to 19