NCT05354713

Brief Summary

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

November 5, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

April 18, 2022

Last Update Submit

May 3, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • NVP-1805's Pharmacokinetics of plasma

    AUCt

    0hours - 72hours

  • Pharmacokinetics of plasma

    Cmax

    0hours - 72hours

Study Arms (2)

NVP-1805

EXPERIMENTAL

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)

Drug: NVP-1805

NVP-1805-R1 and NVP-1805-R2

ACTIVE COMPARATOR

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)

Drug: NVP-1805-R1 and NVP-1805-R2

Interventions

NVP-1805DRUG

NVP-1805 (80/10/20.8mg)

NVP-1805
NVP-1805-R1 and NVP-1805-R2DRUG

coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)

NVP-1805-R1 and NVP-1805-R2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult subjects who signed informed consent
  • BMI of \>18.0 kg/m2 and \<30.0 kg/m2 subject, weight more than 50kg(45 kg or more for woman)

You may not qualify if:

  • Subjects participated in another clinical trial within 6 months prior to administration of the study drug
  • Inadequate subject for the clinical trial by the investigator's decision
  • Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H Plus Yangji Hospita

Seoul, South Korea

Location

Study Officials

  • Jaewoo Kim

    H Plus Yangji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 29, 2022

Study Start

November 5, 2022

Primary Completion

March 20, 2023

Study Completion

April 27, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations

KR(1)