Evidence map›Paper›PMID 32945153›Full record

Trial reportClinical pharmacology in drug development2020

Pharmacokinetics, Safety, and Tolerability of Single- and Multiple-Dose Once-Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo-Controlled Study.

Xia Zhao, Xiao Yan Sheng, Christopher D Payne, Xin Zhang, Feng Wang, Yi Min Cui

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology in drug development, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 21 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Baricitinib: A Review in Moderate to Severe Atopic Dermatitis.American journal of clinical dermatology · 2022
    Review
  11. Review
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 4 institutions in 2 countries.

Xia ZhaoDepartment of Pharmacy, Peking University First Hospital, Beijing, China.
Xiao Yan ShengDepartment of Pharmacy, Peking University First Hospital, Beijing, China.
Christopher D PayneMedical Department, Eli Lilly and Company, Indianapolis, Indiana, USA.
Xin ZhangMedical Department, Eli Lilly and Company, Indianapolis, Indiana, USA.
Feng WangMedical Department, Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, China.
Yi Min CuiDepartment of Pharmacy, Peking University First Hospital, Beijing, China.
Eli Lilly (United States) · USPeking University First Hospital · CNLuye Pharma (China) · CNPeking University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The objective of this phase 1 study was to evaluate the pharmacokinetics, safety, and tolerability of baricitinib after single and multiple doses in healthy Chinese adults. Eligible subjects received a once-daily dose of baricitinib 2, 4, or 10 mg or placebo on day 1 (single dose) and days 4 through 10 for 7 consecutive days (multiple doses). Plasma pharmacokinetic samples were collected up to 48 hours after dosing on days 1 and 10, with predose samples collected before dosing on day 1 and days 4 through 10. Safety and tolerability were also assessed. Baricitinib was rapidly absorbed, reaching peak plasma concentrations within 0.5 to 1 hour (median). Plasma concentrations declined rapidly following the attainment of peak concentrations, with a mean terminal half-life of 5.7 to 7.3 hours. Steady-state plasma concentrations of baricitinib were achieved after the second day of once-daily dosing, with minimal accumulation of baricitinib in plasma (up to 10% increase in area under the plasma concentration-time curve). Single- and multiple-dose mean values for area under the plasma concentration-time curve from time zero to infinity and maximum plasma concentration appeared to increase in an approximately dose-proportional manner across the dose range. Single and multiple oral doses of once-daily baricitinib up to 10 mg were well tolerated by healthy Chinese subjects.

Indexed as

Administration, OralAdultArea Under CurveArthritis, RheumatoidAsian PeopleAzetidinesCase-Control StudiesDose-Response Relationship, DrugDrug Administration ScheduleDrug ToleranceFemaleHalf-LifeHealthy VolunteersHumansMaleMiddle AgedAzetidinesbaricitinibOxazolesPlacebosPurinesPyrazolesR333SulfonamidesbaricitinibChinaJanus kinase family of protein tyrosine kinasespharmacokineticsrheumatoid arthritis

Identifiers

PMID32945153
PMCPMC9292889
OpenAlexW3087516196

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.