AJ201 Food Effect, Phase 1, Japanese and White Males
ClinicalTrials.gov Studies
Summary
NIH registered a Phase 1 clinical trial (NCT07549919) to evaluate the effect of food on the bioavailability of AJ201 and to assess safety, tolerability, and pharmacokinetics in Japanese and White healthy male participants. The study is described as randomized, single-dose, open-label, and two-way crossover in design. This study registration appears on ClinicalTrials.gov with an anticipated start date of April 24, 2026.
“This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This document registers a new Phase 1 clinical trial on ClinicalTrials.gov. The trial will study how food affects the bioavailability of AJ201, along with safety, tolerability, and pharmacokinetics in healthy male participants of Japanese and White descent. The trial is structured as a randomized, single-dose, open-label, two-way crossover study.
Pharmaceutical sponsors conducting early-phase trials in diverse populations should note this registration reflects increasing regulatory expectations for demographic representation in clinical development programs. Sites and sponsors may need to ensure appropriate infrastructure for food-effect study designs and multi-population enrollment.
Archived snapshot
Apr 25, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
Phase 1 NCT07549919 Kind: PHASE1 Apr 24, 2026
Abstract
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.
Conditions: Healthy Male Adults, Food Effect in Healthy Volunteers
Interventions: AJ201
Mentioned entities
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.