CompletedPhase 1

Single and Multiple Ascending Dose Study With EP395

United Kingdom78 participantsStarted 2021-04-05

Plain-language summary

This is a study to asses the safety and tolerability of single and multiple ascending doses of EP395, administered by oral capsules, in healthy subjects with the aim to determine the safe dose range of EP395 for further clinical development

Who can participate

Age range18 Years – 65 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

✓. Subject's written informed consent obtained prior to any study-related procedures.
✓. Able to understand and comply with the requirements of the study, as judged by the investigator or designee.
✓. Men and women between 18-65 years inclusive
✓. Female subjects must either be of non-childbearing potential or if of childbearing potential, must not be pregnant or breast feeding and use a highly effective birth control method during treatment and for 90 days following last dose
✓. Male subjects must use highly effective contraception during treatment and for 90 days following last administered dose
✓. Subject must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP
✓. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
✓. Subjects with normal hearing

Exclusion criteria

✕. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety.
✕. History or presence of vestibular disorder including vertigo, dizziness or other auditory impairment as judged by the investigator or designee.
✕. After 10 minutes supine rest at the time of screening or prior to dosing, any vital signs values outside the following ranges:
✕. Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (\>450 ms for males; \>470 ms for females) and cardiac arrhythmias, as judged by the Investigator or designee.
✕. Clinically significant abnormalities in renal function:
✕. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP (Day 1).
✕. Malignancy within the past five years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
✕. Any planned major surgery within the duration of the study.

What they're measuring

To assess the safety of EP395

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on ECG

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on temperature

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on blood pressure

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on pulse

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on hearing

Timeframe: from baseline to day 7 and day 42

Trial details

NCT IDNCT04819854

SponsorEpiEndo Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-22

View on ClinicalTrials.gov More Adult ALL trials

Who can participate

Age range18 Years – 65 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

✓. Subject's written informed consent obtained prior to any study-related procedures.
✓. Able to understand and comply with the requirements of the study, as judged by the investigator or designee.
✓. Men and women between 18-65 years inclusive
✓. Female subjects must either be of non-childbearing potential or if of childbearing potential, must not be pregnant or breast feeding and use a highly effective birth control method during treatment and for 90 days following last dose
✓. Male subjects must use highly effective contraception during treatment and for 90 days following last administered dose
✓. Subject must agree not to donate semen or ova/oocytes during the study and for 90 days after the last dose of IMP
✓. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2.
✓. Subjects with normal hearing

Exclusion criteria

✕. History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the subject's safety.
✕. History or presence of vestibular disorder including vertigo, dizziness or other auditory impairment as judged by the investigator or designee.
✕. After 10 minutes supine rest at the time of screening or prior to dosing, any vital signs values outside the following ranges:
✕. Any clinically significant abnormalities in resting ECG at the time of screening or pre-dose Day 1 including prolonged QTcF (\>450 ms for males; \>470 ms for females) and cardiac arrhythmias, as judged by the Investigator or designee.
✕. Clinically significant abnormalities in renal function:
✕. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP (Day 1).
✕. Malignancy within the past five years with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
✕. Any planned major surgery within the duration of the study.

What they're measuring

To assess the safety of EP395

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on ECG

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on temperature

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on blood pressure

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on pulse

Timeframe: from baseline to day 7 and day 42

To assess the effect of EP395 on hearing

Timeframe: from baseline to day 7 and day 42