NCT06916169

Brief Summary

The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2025

Shorter than P25 for phase_1

Status
not yet recruiting

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 2, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

April 2, 2025

Last Update Submit

April 2, 2025

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • AUC

    Area under the plasma concentration

    Pharmacokinetic plasma samples collected over a 72-hour period

  • Cmax

    Peak Plasma Concentration

    Pharmacokinetic plasma samples collected over a 72-hour period

Study Arms (2)

Sequence A

EXPERIMENTAL

Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304

Drug: AG2304Drug: AG23041 and AG23042

Sequence B

ACTIVE COMPARATOR

Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042

Drug: AG2304Drug: AG23041 and AG23042

Interventions

AG2304DRUG

AG2304, Single-dose Oral Administration

Sequence ASequence B
AG23041 and AG23042DRUG

AG23041/AG23042, Single-dose Oral Administration

Sequence ASequence B

Eligibility Criteria

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

You may qualify if:

  • A healthy adults aged 19-65 years at the time of screening
  • Subjects who are deemed eligible based on the screening tests

You may not qualify if:

  • Subjects who have taken the investigational drug within 6 months prior to the first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 2, 2025

First Posted

April 8, 2025

Study Start

August 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04