Evidence map›Paper›PMID 36925997›Full record

Trial reportDrug design, development and therapy2023

Effect of Food on the Pharmacokinetics and Safety of a Novel c-Met Inhibitor SCC244: A Randomized Phase I Study in Healthy Subjects.

Juan Wu, Hongrong Xu, Hui Li, Lei Ma, Juan Chen, Fei Yuan, Lei Sheng, Chao Liu, Weili Chen, Xuening Li

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Drug design, development and therapy, 2023. 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
1.5field-weighted citation impact, top 20% 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, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  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

10 authors at 3 institutions in 1 country.

Juan WuDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.ORCID 0000-0002-0792-5300
Hongrong XuDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.
Hui LiDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.
Lei MaHaihe Biopharma Co., Ltd, Shanghai, People's Republic of China.
Juan ChenHaihe Biopharma Co., Ltd, Shanghai, People's Republic of China.
Fei YuanDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.
Lei ShengDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.
Chao LiuDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.ORCID 0000-0001-5410-5519
Weili ChenDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.
Xuening LiDepartment of Clinical Pharmacology & Cancer Center, ZhongShan Hospital, Fudan University, Shanghai, People's Republic of China.ORCID 0000-0003-3899-5245
Fudan University · CNJiangsu T-mab BioPharma (China) · CNShanghai Jiao Tong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective: This study aimed to investigate the effect of food on the pharmacokinetics and safety profiles of SCC244, a novel oral c-Met inhibitor in healthy Chinese male subjects. Methods: It was a randomized, open-label, and 3-period crossover design, single-dose phase I clinical trial. A total of 18 healthy male subjects were enrolled. These subjects received a single oral 300 mg dose of SCC244 with a 14-day washout between each period. Blood samples were collected at the designated time points and determined using a validated liquid chromatography tandem mass spectrometry method. Pharmacokinetic parameters were calculated by noncompartmental methods. Tolerability was assessed by physical examination, vital sign measurements, 12-lead ECG, clinical laboratory tests, and adverse events (AEs) monitoring throughout the study. Results: Eighteen eligible subjects were enrolled in the study. The ratios (90% CI) of C Conclusion: The bioavailability of the tablet formulation of SCC244 was significantly increased when administered with high- and low-fat meals. However, the meals did not affect the median T

Indexed as

FastingProtein Kinase InhibitorsAdministration, OralArea Under CurveBiological AvailabilityCross-Over StudiesFood-Drug InteractionsHealthy VolunteersHumansMaleTabletsTherapeutic EquivalencyProtein Kinase InhibitorsTabletsc-Met inhibitorfood effectpharmacokineticssafetySCC244

Identifiers

PMID36925997
PMCPMC10013581
OpenAlexW4323854364

What OpenQuestion holds

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LicenceCC BY-NC
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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.