Evidence map›Paper›PMID 28508936›Full record

Trial reportClinical pharmacokinetics2018

Phase I Clinical Study of ZYAN1, A Novel Prolyl-Hydroxylase (PHD) Inhibitor to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Oral Administration in Healthy Volunteers.

Kevinkumar A Kansagra, Deven Parmar, Rajendra H Jani, Nuggehally R Srinivas, Jason Lickliter, Harilal V Patel, Devang P Parikh, Heather Heading, Hardik B Patel, Rahul J Gupta and 7 more

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical pharmacokinetics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.0field-weighted citation impact, top 28% 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

16 citing papers in PubMed, 38 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

17 authors at 3 institutions in 2 countries.

Kevinkumar A KansagraZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Deven ParmarZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India. deven.parmar@zyduscadila.com.
Rajendra H JaniZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Nuggehally R SrinivasZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Jason LickliterDivision of Nucleus Network, Centre for Clinical Studies (CCS), Melbourne, Australia.
Harilal V PatelZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Devang P ParikhZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Heather HeadingCPR Pharma Services Pty Ltd, Thebarton, SA, 5031, Australia.
Hardik B PatelZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Rahul J GuptaZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Chintan Y ShahZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Maulik R PatelZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Vyom N DholakiaCliantha Research Limited, Ahmedabad, India.
Raghav SukhadiyaCliantha Research Limited, Ahmedabad, India.
Mukul R JainZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Krupi V ParmarZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Kinjal BarotZydus Research Center, Survey No. 396/403, Sarkhej-Bavla N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
Cadila Healthcare (India) · INCliantha (India) · INServices Australia · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis phase I study of ZYAN1 was conducted to evaluate the safety, tolerability, and pharmacokinetics following oral administration in healthy volunteers.

methodsThe study was a randomized, double-blind, placebo-controlled phase I study carried out in two parts in addition to a third part involving an open-label study to evaluate the food/sex effect. A total of 100 subjects were enrolled into the study as follows: part I-single-dose study with ZYAN1 10, 25, 50, 100, 150, 200, and 300 mg (n = 56); part II-multiple-dose study with every other day dosing of ZYAN1 100, 150, 200, and 300 mg (n = 32); and part III-sex and food effect study with ZYAN1 150 mg (n = 12; open-label).

resultsZYAN1 was well-tolerated after single and multiple oral ascending doses. No drug-related serious adverse events were reported. Following a single ascending dose of ZYAN1, the maximum concentration (C

conclusionOral single (10-300 mg) and multiple dosing (100-300 mg) of ZYAN1 in healthy subjects was found to be safe and well-tolerated. With increasing ZYAN1 dose, there was almost a proportional increase in mean C

trial registrationAustralian New Zealand Clinical Trials Registry trial ID ACTRN12614001240639.

Indexed as

Administration, OralArea Under CurveDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHalf-LifeHumansMaleProlyl-Hydroxylase InhibitorsQuinolonesdesidustatProlyl-Hydroxylase InhibitorsQuinolones

Identifiers

PMID28508936
PMCPMC5766731
OpenAlexW2614287697

What OpenQuestion holds

Textmetadata
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.