Trial reportClinical drug investigation2016
Vedolizumab Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability Following Administration of a Single, Ascending, Intravenous Dose to Healthy Volunteers.
Trial report in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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
27 citing papers in PubMed.
- Effects of vedolizumab in Japanese patients with Crohn's disease: a prospective, multicenter, randomized, placebo-controlled Phase 3 trial with exploratory analyses.Journal of gastroenterology · 2020Trial
- Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation.Alimentary pharmacology & therapeutics · 2019Trial
- Physiologically Based Pharmacokinetic Modeling of Vedolizumab in Healthy Adults and Patients with Inflammatory Bowel Disease.Clinical pharmacokinetics · 2026Article
- Reactive Therapeutic Drug Monitoring Guides Optimal Management of Adalimumab Failure in Pediatric Crohn's Disease: A Real-World Single-Center Experience.Pediatric gastroenterology, hepatology & nutrition · 2026Article
- Optimizing Maternal and Fetal Antibody Exposure and Dosing Regimens During Pregnancy Using a Physiologically Based Pharmacokinetic Model.Clinical pharmacology and therapeutics · 2025Article
- Vedolizumab Clearance as a Surrogate Marker for Remission in Inflammatory Bowel Disease Patients: Insights from Real-World Pharmacokinetics.Pharmaceutics · 2024Article
- Mathematical Modeling of Vedolizumab Treatment's Effect on Microbiota and Intestinal Permeability in Inflammatory Bowel Disease Patients.Bioengineering (Basel, Switzerland) · 2024Article
- Effectiveness and safety outcomes after long-term (54 weeks) vedolizumab therapy for Crohn's disease: a prospective, real-world observational study including patient-reported outcomes (POLONEZ II).Therapeutic advances in gastroenterology · 2024Article
- Pharmacokinetics and Safety of Vedolizumab Following Administration of a Single Intravenous Dose in Healthy Chinese Subjects.European journal of drug metabolism and pharmacokinetics · 2023Article
- Effectiveness of Ustekinumab Dose Escalation in Patients With Crohn's Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2021Article
- Article
- Therapeutic Drug Monitoring of Biologics During Induction to Prevent Primary Non-Response.Journal of Crohn's & colitis · 2020Review
- Biomarkers are associated with clinical and endoscopic outcomes with vedolizumab treatment in Crohn's disease.Therapeutic advances in gastroenterology · 2020Article
- A Phase 1, Multiple-Dose Study of Vedolizumab in Japanese Patients With Ulcerative Colitis.Journal of clinical pharmacology · 2019Article
- Biomarkers Are Associated With Clinical and Endoscopic Outcomes With Vedolizumab Treatment in Ulcerative Colitis.Inflammatory bowel diseases · 2019Article
- A product review of vedolizumab in inflammatory bowel disease.Human vaccines & immunotherapeutics · 2019Review
- Clinical Pharmacokinetic and Pharmacodynamic Considerations in the Treatment of Ulcerative Colitis.Clinical pharmacokinetics · 2019Review
- Predictors and Management of Loss of Response to Vedolizumab in Inflammatory Bowel Disease.Inflammatory bowel diseases · 2018Article
- Identification of Candidate Biomarkers Associated with Response to Vedolizumab in Inflammatory Bowel Disease.Digestive diseases and sciences · 2018Observational
- The Role of Integrin αCurrent HIV/AIDS reports · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesVedolizumab, a humanized monoclonal antibody against the α
methodsForty-nine participants (in five cohorts) were randomly assigned in a 4:1 ratio to receive a single intravenous infusion of either vedolizumab (0.2, 0.5, 2.0, 6.0, or 10.0 mg/kg) or placebo. Blood samples were collected for measurement of vedolizumab serum concentrations and α
resultsVedolizumab maximum observed serum concentration (C
conclusionsVedolizumab exhibited target-mediated disposition, characterized by a rapid, saturable, nonlinear elimination process at low concentrations and a slower linear elimination process at higher concentrations. Nearly complete α
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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.