NCT04309526

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

Double-Blind, Placebo-Controlled, Randomized, Ascending Single Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of NCO-48 Fumarate in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Nucorion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a first-in-human, double-blind, placebo-controlled, randomized, ascending single oral dose study. NCO-48 Fumarate will be assessed in healthy subjects (6 groups of 8 subjects each). Subjects will receive a single oral dose of NCO-48 Fumarate or placebo capsules in 1 or 2 periods, depending on the dose group, under fasting conditions (unless otherwise indicated) and will be followed for a 1-week observation period. Safety assessments will be performed and NCO-48 Fumarate and TFV PK will be assessed. The planned doses for this study are 2, 10, 30, 60, 120, and 240 mg. Each group of 8 subjects (Groups 1 to 6) will be randomized in a 3:1 ratio to receive either NCO-48 Fumarate or placebo (6 subjects to receive active drug and 2 subjects to receive placebo) as a single dose on Day 1 of Period 1 in the fasted state. A preliminary assessment of food effect will be conducted in Group 3. Subjects in Group 3 will receive study drug in Period 1 under fasted conditions and return after a minimum of 14 days to receive study drug under fed conditions. There will be a Screening Period of up to 30 days. All subjects (Periods 1 and 2) will be observed through the morning of Day 3 (48-hour post-dose assessment). Safety assessments and NCO-48 Fumarate and TFV PK sample collection (blood and urine) will occur during this time. Subjects will be discharged from the study site after the 48 hour assessments and return to the study site on Days 5 and 7 (final visit) for follow-up procedures. After the Day 7 follow-up procedures for each group, evaluation of all safety and tolerability data collected during the period, and evaluation of any available PK data, the dose for the next group of subjects will be determined by the Safety Monitoring Panel (SMP).

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	NCO-48 Fumarate	NCO-48 Fumarate
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-03-18
• Primary completion: 2020-08-03
• Completion: 2020-10-13
• First posted: 2020-03-16
• Last updated: 2020-11-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study