Who is sponsoring NCT02135263?

NCT02135263 is sponsored by Bispebjerg Hospital.

What drugs are being tested in NCT02135263?

Interventions in NCT02135263: Methylphenidate, Enalapril.

What condition does NCT02135263 study?

NCT02135263 studies Carboxylesterase 1 (CES1) Genotype, CES1 Activity.

Is NCT02135263 still recruiting?

NCT02135263 is currently completed. Last updated 29 July 2014.

Last reviewed 2014-07-29 · How we verify

NCT02135263

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

Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype

Completed Phase 4 Last updated 29 July 2014

What this trial tests

Phase 4 trial testing Methylphenidate in Carboxylesterase 1 (CES1) Genotype in 44 participants. Completed in 1 May 2014.

Timeline

1 April 2012

Primary endpoint
1 May 2014

1 May 2014

Quick facts

Lead sponsor	Bispebjerg Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	44
Start date	1 April 2012
Primary completion	1 May 2014
Estimated completion	1 May 2014
Sites	1 location across Denmark

Drugs / interventions tested

Methylphenidate (methylphenidate) — full drug profile →
Enalapril (enalapril) — full drug profile →

Conditions studied

Carboxylesterase 1 (CES1) Genotype — all drugs for Carboxylesterase 1 (CES1) Genotype →
CES1 Activity — all drugs for CES1 Activity →

Sponsor

Bispebjerg Hospital

Who can join

18 and older, any sex, with Carboxylesterase 1 (CES1) Genotype or CES1 Activity. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Peak plasma concentration (Cmax) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Time to peak plasma concentration (Tmax) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Terminal half life (t½) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Area under the plasma concentration versus time curve (AUC) of methylphenidate
Time frame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
Peak plasma concentration (Cmax) of enalapril
Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Time to peak plasma concentration (Tmax) of enalapril
Time frame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose

Sponsor's own description

The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1 dependent drugs, enalapril and methylphenidate.

Publications & conference data

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

The impact of CES1 genotypes on the pharmacokinetics of methylphenidate in healthy Danish subjects.
Stage C, Jürgens G, Guski LS, Thomsen R, et al · · 2017 · cited 38× · PMID 28087982 · DOI 10.1111/bcp.13237
Population Pharmacokinetics of Methylphenidate in Healthy Adults Emphasizing Novel and Known Effects of Several Carboxylesterase 1 (CES1) Variants.
Lyauk YK, Stage C, Bergmann TK, Ferrero-Milliani L, et al · · 2016 · cited 12× · PMID 27754602 · DOI 10.1111/cts.12423

Verify or expand the search:

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Other Bispebjerg Hospital trials

Trials by the same sponsor.

NCT06872060 — The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance. · NA · not yet recruiting
NCT07373587 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy · NA · not yet recruiting
NCT07123558 — Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men · NA · not yet recruiting
NCT07124338 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibili · NA · active not recruiting
NCT07096648 — Alert Burden When Monitoring Patients at Home · active not 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 NCT02135263 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Bispebjerg Hospital
Last refreshed: 29 July 2014

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/NCT02135263.

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