Evidence map›Paper›PMID 30740895›Full record

Trial reportClinical and translational science2019

Safety, Pharmacokinetics, and Pharmacodynamics of ASP3662, a Novel 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor, in Healthy Young and Elderly Subjects.

Susan Bellaire, Mark Walzer, Tianli Wang, Walter Krauwinkel, Nancy Yuan, Gerard J Marek

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. 11β-HSD as a New Target in Pharmacotherapy of Metabolic Diseases.International journal of molecular sciences · 2022
    Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. 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.

Susan BellaireFormerly with Astellas Pharma Europe BV, Leiden, The Netherlands.
Mark WalzerAstellas Pharma Global Development, Northbrook, Illinois, USA.
Tianli WangFormerly with Astellas Pharma, Inc., Northbrook, Illinois, USA.
Walter KrauwinkelAstellas Pharma, Inc., Leiden, The Netherlands.
Nancy YuanFormerly with Astellas Pharma, Inc., Northbrook, Illinois, USA.
Gerard J MarekAstellas Pharma, Inc., Northbrook, Illinois, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Inhibition of the enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) represents a potential mechanism for improving pain conditions. ASP3662 is a potent and selective inhibitor of 11β-HSD1. Two phase I clinical studies were conducted to assess the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of single and multiple ascending doses of ASP3662 in healthy young and elderly non-Japanese and young Japanese subjects. Nonlinear, more than dose-proportional PKs were observed for ASP3662 after single-dose administration, particularly at lower doses (≤ 6 mg); the PKs at steady state were dose proportional, although the time to ASP3662 steady state was dose dependent at lower doses (≤ 2 mg). Similar PKs were observed among young Japanese, young non-Japanese, and elderly non-Japanese subjects. Specific inhibition of 11β-HSD1 occurred after both single and multiple doses of ASP3662. A marked dissociation between PKs and PDs was observed after single but not multiple doses of ASP3662. ASP3662 was generally safe and well tolerated.

Indexed as

11-beta-Hydroxysteroid Dehydrogenase Type 1AdolescentAdultAgedBenzamidesDose-Response Relationship, DrugEnzyme InhibitorsFemaleHumansMaleMiddle AgedTriazolesYoung Adult11-beta-Hydroxysteroid Dehydrogenase Type 1ASP3662BenzamidesEnzyme InhibitorsTriazoles

Identifiers

PMID30740895
PMCPMC6510378

What OpenQuestion holds

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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.