Evidence map›Paper›PMID 27272171›Full record

Trial reportClinical pharmacokinetics2016

Pharmacokinetics, Safety and Tolerability of ABT-494, a Novel Selective JAK 1 Inhibitor, in Healthy Volunteers and Subjects with Rheumatoid Arthritis.

Mohamed-Eslam F Mohamed, Heidi S Camp, Ping Jiang, Robert J Padley, Armen Asatryan, Ahmed A Othman

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01741493 (A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494), which is not on this map. Cited by 59 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 4% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT01741493 phase1completednot on this map

A Study in Healthy Adult Volunteers and Adult Subjects With Rheumatoid Arthritis to Evaluate the Safety, Tolerability, and Pharmacokinetics After Multiple Dosing of ABT-494

TypeinterventionalSponsorAbbVie (prior sponsor, Abbott)Ran2012 to 2013Enrolled67ConditionsRheumatoid ArthritisArmsABT-494, Placebo, Tofacitinib
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 1 synthesis or guideline pooled it, 115 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Mohamed-Eslam F MohamedClinical Pharmacology and Pharmacometrics, AbbVie, 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA.
Heidi S CampImmunology Development, AbbVie, North Chicago, IL, USA.
Ping JiangClinical Pharmacology and Pharmacometrics, AbbVie, 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA.
Robert J PadleyImmunology Development, AbbVie, North Chicago, IL, USA.
Armen AsatryanImmunology Development, AbbVie, North Chicago, IL, USA.
Ahmed A OthmanClinical Pharmacology and Pharmacometrics, AbbVie, 1 North Waukegan Road, Bldg. AP31-3, North Chicago, IL, 60064, USA. ahmed.othman@abbvie.com.
AbbVie (United States) · USCairo University · EG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundABT-494 is a potent and selective Janus kinase (JAK) 1 inhibitor being developed for the treatment of several autoimmune disorders, with potential for an improved safety profile compared with non-selective JAK inhibitors. This work characterized the pharmacokinetics, safety, and tolerability of ABT-494 following single and multiple dosing of the immediate-release formulation.

methodsABT-494 single (1-48 mg or placebo; n = 56) and multiple (3-24 mg or placebo twice daily for 14 days; n = 44) doses in healthy subjects, as well as multiple doses (3-24 mg or placebo twice daily for 27 days; n = 14) in subjects with rheumatoid arthritis (RA) on a background of methotrexate were evaluated. Pharmacokinetic samples were collected and safety and tolerability were assessed.

resultsABT-494 followed bi-exponential disposition, with a terminal elimination half-life of 6-16 h and a functional half-life, calculated from maximum observed plasma concentration (C

conclusionsThe favorable pharmacokinetics, safety, and tolerability results from these studies supported further evaluations of ABT-494 in phase IIb dose-ranging trials in RA and Crohn's disease.

trial registrationClinicalTrials.gov ( https://clinicaltrials.gov/ ) identifier: NCT01741493.

Indexed as

Administration, OralAdolescentAdultAgedAntirheumatic AgentsArea Under CurveArthritis, RheumatoidDrug Administration ScheduleFemaleHalf-LifeHealthy VolunteersHeterocyclic Compounds, 3-RingHumansJanus Kinase 1MaleMetabolic Clearance RateAntirheumatic AgentsHeterocyclic Compounds, 3-RingJanus Kinase 1upadacitinib

Identifiers

PMID27272171
OpenAlexW2415732068

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.