Evidence map›Paper›PMID 37219453›Full record

Trial reportAntimicrobial agents and chemotherapy2023

Phase I Single Ascending Dose and Food Effect Study in Healthy Adults and Phase I/IIa Multiple Ascending Dose Study in Patients with Pulmonary Tuberculosis to Assess Pharmacokinetics, Bactericidal Activity, Tolerability, and Safety of OPC-167832.

Rodney Dawson, Andreas H Diacon, Kim Narunsky, Veronique R De Jager, Kelly W Stinson, Xiaoyan Zhang, Yongge Liu, Jeffrey Hafkin

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.3field-weighted citation impact, top 12% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

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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 3 institutions in 2 countries.

Rodney DawsonDivision of Pulmonology, Department of Medicine, University of Cape Town and University of Cape Town Lung Institute, Cape Town, South Africa.
Andreas H DiaconTASK Applied Science, Cape Town, South Africa.
Kim NarunskyDivision of Pulmonology, Department of Medicine, University of Cape Town and University of Cape Town Lung Institute, Cape Town, South Africa.
Veronique R De JagerTASK Applied Science, Cape Town, South Africa.
Kelly W StinsonCultura, LLC, Decatur, Georgia, USA.
Xiaoyan ZhangOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.
Yongge LiuOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.ORCID 0000-0002-3982-4176
Jeffrey HafkinOtsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.ORCID 0000-0002-6690-3240
Pharmaceutical Product Development (United States) · USTask Applied Science · ZAUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

OPC-167832, an inhibitor of decaprenylphosphoryl-β-d-ribose 2'-oxidase, demonstrated potent antituberculosis activity and a favorable safety profile in preclinical studies. This report describes the first two clinical studies of OPC-167832: (i) a phase I single ascending dose (SAD) and food effects study in healthy participants; and (ii) a 14-day phase I/IIa multiple ascending dose (MAD; 3/10/30/90 mg QD) and early bactericidal activity (EBA) trial in participants with drug-susceptible pulmonary tuberculosis (TB). OPC-167832 was well tolerated at single ascending doses (10 to 480 mg) in healthy participants and multiple ascending doses (3 to 90 mg) in participants with TB. In both populations, nearly all treatment-related adverse events were mild and self-limiting, with headache and pruritus being the most common events. Abnormal electrocardiograms results were rare and clinically insignificant. In the MAD study, OPC-167832 plasma exposure increased in a less than dose-proportional manner, with mean accumulation ratios ranging from 1.26 to 1.56 for

Indexed as

Tuberculosis, PulmonaryAdultArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodFastingFoodHealthy VolunteersHumansantibacterialbactericidal activitydecaprenylphosphoryl-β-d-ribose 2-oxidaseOPC-167832pharmacokineticsphase I/IIa studyphase I studysafety and tolerabilitytuberculosis

Identifiers

PMID37219453
PMCPMC10269160
OpenAlexW4377565638

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.