Evidence map›Paper›PMID 31628854›Full record

Trial reportClinical pharmacology and therapeutics2020

Single Therapeutic and Supratherapeutic Doses of Ubrogepant Do Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized Trial.

Abhijeet Jakate, Ramesh Boinpally, Matthew Butler, Kaifeng Lu, Danielle McGeeney, Antonia Periclou

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Trial
  3. A Human Mass Balance and Metabolism Study of [Clinical pharmacology in drug development · 2026
    Article
  4. Review
  5. Review
  6. Article
  7. Ubrogepant to Treat Acute Migraine in Adults.Neurology international · 2021
    Review
  8. Review
  9. Review
  10. 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

6 authors.

Abhijeet JakateAllergan plc, Madison, New Jersey, USA.
Ramesh BoinpallyAllergan plc, Madison, New Jersey, USA.
Matthew ButlerAllergan plc, Madison, New Jersey, USA.
Kaifeng LuAllergan plc, Madison, New Jersey, USA.
Danielle McGeeneyAllergan plc, Madison, New Jersey, USA.
Antonia PericlouAllergan plc, Madison, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ubrogepant is a novel, oral calcitonin gene-related peptide receptor antagonist currently under US Food and Drug Administration (FDA) review for the acute treatment of migraine attacks. This double-blind, four-period crossover study compared the cardiac repolarization effect of therapeutic (100 mg) and supratherapeutic (400 mg) ubrogepant doses vs. placebo in healthy adults. Moxifloxacin 400 mg was used as an open-label active control, and the primary end point was change from baseline in Fridericia-corrected QT intervals (ΔQTcF). Assay sensitivity was demonstrated via statistically significant QTcF prolongation with moxifloxacin vs. placebo. After single oral doses of ubrogepant, the least squares mean placebo-corrected ΔQTcF (ΔΔQTcF) and 90% confidence intervals (CIs) did not exceed the 10-millisecond regulatory threshold at any timepoint. The 90% CI upper bounds were 2.46 milliseconds and 2.69 milliseconds for ubrogepant 100 and 400 mg, respectively. Categorical and concentration-based analyses were consistent with the primary result, showing no significant impact of ubrogepant on cardiac repolarization.

Indexed as

AdolescentAdultCalcitonin Gene-Related Peptide Receptor AntagonistsCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodFemaleHealthy VolunteersHeart RateHumansMaleMiddle AgedPyridinesPyrrolesYoung AdultCalcitonin Gene-Related Peptide Receptor AntagonistsPyridinesPyrrolesubrogepant

Identifiers

PMID31628854
PMCPMC7158215

What OpenQuestion holds

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LicenceCC BY-NC
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.