Trial reportDrug design, development and therapy2025
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Oral Doses of ABP-671 in Healthy and Hyperuricemic Subjects.
Trial report in Drug design, development and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and food effects of single and multiple oral doses of ABP-671, a novel URAT1 inhibitor, in healthy and hyperuricemic subjects. Patients and Methods: This placebo-controlled study of ABP-671 was conducted in the United States, and contained three parts: a. single ascending dose (SAD); b. multiple ascending dose (MAD); c. food effect. The study doses of SAD part, 0.1, 0.5, and 1.0 mg, and placebo oral solutions were investigated in healthy volunteers. In the MAD study, hyperuricemic but otherwise healthy subjects received 0.2, 0.5, or 1.0 mg/d of ABP-671 or placebo oral solutions for 10 days. In the food effect study, healthy subjects received 1.0 mg ABP-671 tablet in the fasted or fed state in a crossover design. Results: A total of 24, 27, and 12 subjects were enrolled, with 5, 9, and 5 treatment-emergent adverse events (TEAEs) observed in the SAD, MAD, and food effect studies, respectively. There were no serious adverse events (SAEs) or TEAEs leading to discontinuation or death. In the SAD and MAD studies, the peak plasma concentration and areas under the curves increased with the increasing drug doses. The serum uric acid (sUA) levels started decreasing 3 hours after ABP-671 administration, and the percentage changes from baseline for sUA increased with the increasing drug doses. Fasting or postprandial state did not affect the PK of ABP-671. Conclusion: Single or multiple oral doses of ABP-671 are well tolerated at doses 0.1, 0.5 and 1.0 mg for the SAD, 0.2, 0.5, and 1.0 mg/d for the MAD, and 1.0 mg for the food effect study. A proportional relationship between dose and exposure was observed. ABP-671 reduced the sUA levels with a rapid (3 hours) onset and in a dose responsive manner.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.