Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04783753
Other study ID # EDP 514-003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 5, 2020
Est. completion date July 9, 2021

Study information

Verified date August 2021
Source Enanta Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 9, 2021
Est. primary completion date June 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - An informed consent document signed and dated by the subject. - Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive - Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-514. - Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. Exclusion Criteria: - Clinically relevant evidence or history of illness or disease - Pregnant or nursing females. - History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of clinically significant active infection. - A positive urine drug screen at Screening or Day -1. - Current tobacco smokers or use of tobacco products within 3 months prior to Screening. - Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). • Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants). - History of regular alcohol consumption - Participation in a clinical trial within 30 days prior to the first dose of study drug. For Part 2 (Carbamazepine) participants: - Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population. - Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EDP-514
Subjects will receive EDP-514 on Days 1 and 14
EDP-514
Subjects will receive EDP-514 on Days 1 and 23
EDP-514
Subjects will receive EDP-514 on Days 1 and 8
Itraconazole
Subjects will receive itraconazole QD for 14 days
Carbamazepin
Subjects will receive carbamazepine BID for 23 days
Quinidine
Subjects will receive quinidine BID for 8 days

Locations

Country Name City State
United States Pharmaceutical Research Association Lenexa Kansas

Sponsors (2)

Lead Sponsor Collaborator
Enanta Pharmaceuticals PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cmax of EDP-514 with and without coadministration with itraconazole up to 19 days
Primary AUC of EDP-514 with and without coadministration with itraconazole 19 days
Primary Cmax of EDP-514 with and without coadministration with carbamazepine up to 28 days
Primary AUC of EDP-514 with and without coadministration with carbamazepine up to 28 days
Primary Cmax of EDP-514 with and without coadministration with quinidine up to 13 days
Primary AUC of EDP-514 with and without coadministration with quinidine up to 13 days
Secondary Safety measured by adverse events up to 34 days
See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A