Evidence map›Paper›PMID 29066863›Full record

Trial reportDrug design, development and therapy2017

Pharmacokinetic and safety evaluation of MB12066, an NQO1 substrate.

Hae Won Lee, Sook Jin Seong, Boram Ohk, Woo Youl Kang, Mi-Ri Gwon, Bo Kyung Kim, Hyun-Ju Kim, Young-Ran Yoon

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Drug design, development and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Clinical Evidence for Targeting NAD Therapeutically.Pharmaceuticals (Basel, Switzerland) · 2020
    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

8 authors.

Hae Won Lee *Clinical Trial Center, Kyungpook National University Hospital.
Sook Jin Seong *Clinical Trial Center, Kyungpook National University Hospital.
Boram OhkClinical Trial Center, Kyungpook National University Hospital.
Woo Youl KangClinical Trial Center, Kyungpook National University Hospital.
Mi-Ri GwonClinical Trial Center, Kyungpook National University Hospital.
Bo Kyung KimClinical Trial Center, Kyungpook National University Hospital.
Hyun-Ju KimCell and Matrix Research Institute, Daegu, Republic of Korea.
Young-Ran YoonClinical Trial Center, Kyungpook National University Hospital.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study evaluated the pharmacokinetics (PKs) and safety of a newly developed β-lapachone (MB12066) tablet, a natural NAD(P)H:quinone oxidoreductase 1 (NQO1) substrate, in healthy male volunteers.

methodsIn a randomized, double-blind, multiple-dose, two-treatment study, 100 mg MB12066 or placebo was given twice daily for 8 days to groups of eight or three fasted healthy male subjects, respectively, followed by serial blood sampling. Plasma concentrations for β-lapachone were determined using liquid chromatography-tandem mass spectrometry. PK parameters were obtained with non-compartmental analysis. Tolerability was assessed based on physical examinations, vital signs, clinical laboratory tests, and electrocardiograms.

resultsFollowing a single 100 mg MB12066 oral dose, maximum plasma concentration (

conclusionThe results demonstrated that MB12066 was safe and well tolerated in healthy volunteers and that there were no serious AEs. Accumulation in plasma with twice-daily administration was associated with a 2.72 accumulation ratio.

Indexed as

Administration, OralAdultArea Under CurveChromatography, LiquidDouble-Blind MethodHalf-LifeHumansMaleNAD(P)H Dehydrogenase (Quinone)NaphthoquinonesTabletsTandem Mass SpectrometryYoung Adultbeta-lapachoneNAD(P)H Dehydrogenase (Quinone)NaphthoquinonesNQO1 protein, humanTabletshealthy volunteersMB12066pharmacokineticssafetyβ-lapachone

Identifiers

PMID29066863
PMCPMC5604554

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Registered trials

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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.