Forward Pharmaceuticals closes enrollment in FWD1802 food-effect PK study
The Phase 1 trial moved to Active, not recruiting as its primary completion date shifted from May 1 to July 6, 2026, with results still pending.
Executive Summary
- A Phase 1 pharmacokinetic trial testing how food affects absorption of Forward Pharmaceuticals' oral drug FWD1802 has finished enrolling and moved to Active, not recruiting, with its data-collection date pushed back roughly two months.
- The study measures drug exposure in healthy volunteers under fed and fasted conditions, not clinical benefit, so its output is a dosing-label input rather than an efficacy signal.
- Enrollment held exactly at its target and the protocol shows a single completion-date amendment, both consistent with normal execution for a trial at this stage.
- The result will inform how FWD1802 is dosed relative to meals in the sponsor's active breast cancer trials, giving it a narrow but concrete downstream use.
The status change
Forward Pharmaceuticals Co., Ltd. updated the registry record for NCT07476963 on July 16, 2026, moving the trial's status from Not yet recruiting to Active, not recruiting and confirming its 18-subject enrollment target was met without expansion or reduction. The same update revised the primary completion date from May 1, 2026 to July 6, 2026, and set overall trial completion at September 1, 2026. The trial started dosing on March 15, 2026, so the status change and completion-date shift both land inside the study's original operating window. NCT07476963+1Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy SubjectsNCT07476963Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy SubjectsJul 16, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial measures
This is an open-label, randomized, three-arm pharmacokinetic study in healthy Chinese adults, not a disease trial: it enrolls Healthy Volunteers to compare drug exposure after fed versus fasted dosing of oral FWD1802. Its three primary endpoints are AUC0-t, AUC0-infinity, and Cmax, plasma-exposure measures assessed over 240 hours after dosing, alongside eleven secondary pharmacokinetic and safety measures including adverse-event monitoring. No primary or secondary results have posted on ClinicalTrials.gov as of this update. NCT07476963Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy SubjectsNCT07476963
Operational read
Enrollment sat flat at 18 of 18 anticipated subjects, a 0% change the operational model treats as typical rather than a deviation for a trial at this stage. The registry-churn proxy for this trial reads Stable, with one recorded amendment cycle since the study record was added on March 17, 2026. The single completion-date change, from May 1 to July 6, tracks with a study that began dosing on schedule and closed enrollment on time, rather than signaling slippage. NCT07476963Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy SubjectsNCT07476963
Where FWD1802 stands
FWD1802 is also in two Phase 1/2 trials in ER-positive, HER2-negative breast cancer, one testing combination therapies (enrollment target 196 subjects, primary completion targeted for May 2028) and one testing FWD1802 against an estrogen receptor and CDK4/6 target set (enrollment target 99, both recruiting). The food-effect study running now sits apart from those efficacy trials: its purpose is to establish whether patients need to take FWD1802 with or without food, an input that typically feeds into dosing instructions for the drug's clinical program rather than a standalone regulatory milestone.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.