NCT01856634 is a Phase 1 clinical trial of 100 mg Delamanid in Multidrug Resistant Tuberculosis, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

Who is sponsoring NCT01856634?

NCT01856634 is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc..

What drugs are being tested in NCT01856634?

Interventions in NCT01856634: 100 mg Delamanid, 50 mg Delamanid, 25 mg Pediatric Formulation Delamanid, 10 mg Delamanid Pediatric Formulation, 5 mg Delamanid Pediatric Formulation, Optimized Background Regimen.

What condition does NCT01856634 study?

NCT01856634 studies Multidrug Resistant Tuberculosis, Pediatric.

Is NCT01856634 still recruiting?

NCT01856634 is currently completed. Last updated 30 January 2018.

Last reviewed 2018-01-30 · How we verify

NCT01856634

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis

Completed Phase 1 Last updated 30 January 2018

What this trial tests

Phase 1 trial testing 100 mg Delamanid in Multidrug Resistant Tuberculosis in 37 participants. Completed in 28 December 2017.

Timeline

14 June 2013

Primary endpoint
10 December 2017

28 December 2017

Quick facts

Lead sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	14 June 2013
Primary completion	10 December 2017
Estimated completion	28 December 2017
Sites	2 locations across Philippines, South Africa

Drugs / interventions tested

100 mg Delamanid — full drug profile →
50 mg Delamanid — full drug profile →
25 mg Pediatric Formulation Delamanid — full drug profile →
10 mg Delamanid Pediatric Formulation — full drug profile →
5 mg Delamanid Pediatric Formulation — full drug profile →
Optimized Background Regimen

Conditions studied

Multidrug Resistant Tuberculosis — all drugs for Multidrug Resistant Tuberculosis →
Pediatric — all drugs for Pediatric →

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. — full company profile →

Who can join

Under 17, any sex, with Multidrug Resistant Tuberculosis or Pediatric. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this trial is to determine the pediatric dose of delamanid that is equivalent to the adult dose already shown to be effective against multidrug-resistant tuberculosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

New agents for the treatment of drug-resistant Mycobacterium tuberculosis.
Hoagland DT, Liu J, Lee RB, Lee RE. · · 2016 · cited 218× · PMID 27151308 · DOI 10.1016/j.addr.2016.04.026
Perspectives on Advances in Tuberculosis Diagnostics, Drugs, and Vaccines.
Schito M, Migliori GB, Fletcher HA, McNerney R, et al · · 2015 · cited 77× · PMID 26409271 · DOI 10.1093/cid/civ609
The role of delamanid in the treatment of drug-resistant tuberculosis.
Lewis JM, Sloan DJ. · · 2015 · cited 50× · PMID 25999726 · DOI 10.2147/tcrm.s71076
New anti-tuberculosis drugs and regimens: 2015 update.
D'Ambrosio L, Centis R, Sotgiu G, Pontali E, et al · · 2015 · cited 42× · PMID 27730131 · DOI 10.1183/23120541.00010-2015
New Drugs for the Treatment of Tuberculosis.
Ignatius EH, Dooley KE. · · 2019 · cited 39× · PMID 31731986 · DOI 10.1016/j.ccm.2019.08.001
Profile of delamanid for the treatment of multidrug-resistant tuberculosis.
Szumowski JD, Lynch JB. · · 2015 · cited 37× · PMID 25678771 · DOI 10.2147/dddt.s60923
Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons.
Gupta A, Hughes MD, Garcia-Prats AJ, McIntire K, et al · · 2019 · cited 34× · PMID 31415563 · DOI 10.1371/journal.pmed.1002882
MDR Tuberculosis Treatment.
Espinosa-Pereiro J, Sánchez-Montalvá A, Aznar ML, Espiau M. · · 2022 · cited 26× · PMID 35208510 · DOI 10.3390/medicina58020188

Verify or expand the search:

Other recruiting trials for Multidrug Resistant Tuberculosis

Currently open trials in the same condition.

NCT05081401 — Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tube · Phase 3 · recruiting

Other Otsuka Pharmaceutical Development & Commercialization, Inc. trials

Trials by the same sponsor.

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NCT07314333 — A Trial to Assess How Centanafadine Interacts With Stimulants in the Body · Phase 1 · recruiting
NCT07329621 — A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01856634 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 30 January 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01856634.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing