Evidence map›Paper›PMID 32515832›Full record

Trial reportJournal of clinical pharmacology2020

An Open-Label Study to Assess the Effect of Itraconazole and Rifampin on Parsaclisib Pharmacokinetics When Administered Orally in Healthy Participants.

Jia Li, Kevin Rockich, Brad Yuska, Gongfu Zhou, Noam Epstein, Naresh Punwani, Xuejun Chen, Swamy Yeleswaram

Open access · hybridAbstract readClinical Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Targeting fibrosis, mechanisms and cilinical trials.Signal transduction and targeted therapy · 2022
    Review
  5. Article
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

8 authors at 1 institution in 1 country.

Jia LiIncyte Research Institute, Wilmington, Delaware, USA.
Kevin RockichIncyte Research Institute, Wilmington, Delaware, USA.
Brad YuskaIncyte Research Institute, Wilmington, Delaware, USA.
Gongfu ZhouIncyte Research Institute, Wilmington, Delaware, USA.
Noam EpsteinIncyte Research Institute, Wilmington, Delaware, USA.
Naresh PunwaniIncyte Research Institute, Wilmington, Delaware, USA.
Xuejun ChenIncyte Research Institute, Wilmington, Delaware, USA.
Swamy YeleswaramIncyte Research Institute, Wilmington, Delaware, USA.
Incyte (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Parsaclisib, a selective, potent phosphatidylinositol 3-kinase delta inhibitor being developed for the treatment of cancer and autoimmune diseases, is primarily metabolized by cytochrome P450 (CYP) 3A4. This study assessed the pharmacokinetics (PK) and safety of parsaclisib alone or combined with itraconazole (potent CYP3A inhibitor) or rifampin (potent CYP3A4 inducer) in healthy participants. In this open-label, fixed-sequence study, cohort 1 received oral parsaclisib 10 mg once daily on days 1 and 8 and oral itraconazole 200 mg once daily on days 4-11; cohort 2 received oral parsaclisib 20 mg once daily on days 1 and 11 and oral rifampin 600 mg once daily on days 4-12. Parsaclisib plasma concentration was tested and PK parameters calculated by noncompartmental analysis. Geometric mean ratios (GMRs) and 2-sided 90% confidence intervals (CIs) were estimated by 2-factor analysis of variance. Thirty-six healthy participants were enrolled (18 per cohort). Parsaclisib maximum plasma drug concentration (C

Indexed as

Administration, OralAdultArea Under CurveCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsDrug InteractionsFemaleHealthy VolunteersHumansItraconazoleMaleMiddle AgedProtein Kinase InhibitorsPyrazolesPyrimidinesCYP3A4 protein, humanCytochrome P-450 CYP3ACytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A InhibitorsItraconazoleparsaclisibProtein Kinase InhibitorsPyrazolesPyrimidinesPyrrolidinesRifampindrug-drug interactionINCB050465parsaclisibpharmacokineticsPI3Kδ inhibitor

Identifiers

PMID32515832
PMCPMC7586811
OpenAlexW3033447244

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.