MedTrace Logo

Safety, Tolerability and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects

NCT04309526 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-11-03

No results posted yet for this study

Summary

The primary objective is to evaluate the safety and tolerability of single oral doses of NCO-48 Fumarate in healthy subjects. The secondary objectives are to evaluate the pharmacokinetic (PK) profile of NCO-48 Fumarate and its active metabolite, tenofovir (TFV), in healthy subjects following single oral doses and to evaluate the effect of food on the PK of a 30 mg dose of NCO-48 Fumarate in healthy subjects.

Conditions

Interventions

DRUG

NCO-48 Fumarate

NCO-48 Fumarate

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    collaborator INDUSTRY

  • Medpace, Inc.

    collaborator INDUSTRY

  • Nucorion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Leela Vrishabhendra, MD · Medpace Clinical Pharmacology Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2020-08-03
Completion
2020-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309526 on ClinicalTrials.gov