At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 99 enrolled
Drug / intervention
KRP-A218 +2 moredrug
Likely dose
itraconazole 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A First-in-Human, Phase I, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects, Including Food-Effect and Drug-drug Interaction With Itraconazole
In Brief
A Phase 1 clinical trial evaluating KRP-A218, Placebo, and 1 other intervention for Healthy. Completed, enrolled 99 participants across 1 site.
Detailed Summary
This first-in-human study has three parts. In Parts A and B, the safety, tolerability, and pharmacokinetics (PK) will be evaluated following administration of single and multiple doses of KRP-A218, including food-effect. In Part C, the drug-drug interaction (DDI) with itraconazole will be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMay 2021
First PostedJun 2021
Primary CompletionApr 2022
TodayJul 2026
First PostedJun 1, 2021
Enrollment StartMay 27, 2021
Primary CompletionApr 21, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.1 years ago
Interventions
KRP-A218drug
KRP-A218 tablet
Placebodrug
Placebo tablet
itraconazoledrug
10 mg/mL oral solution