NCT01458899 (TC-5214) is a Phase 1 clinical trial of TC-5214 in Healthy Subjects, sponsored by AstraZeneca.

Who is sponsoring NCT01458899?

NCT01458899 is sponsored by AstraZeneca.

What drugs are being tested in NCT01458899?

Interventions in NCT01458899: TC-5214.

What condition does NCT01458899 study?

NCT01458899 studies Healthy Subjects.

Is NCT01458899 still recruiting?

NCT01458899 is currently completed. Last updated 10 January 2012.

Last reviewed 2012-01-10 · How we verify

NCT01458899: TC-5214

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

Phase I, Open-label, Randomized, Single-dose, Two Treatment (Fed Versus Fasted) Crossover Study to Assess the Effects of Food on the Pharmacokinetics of TC-5214 (S-Mecamylamine) in Healthy Subjects

Completed Phase 1 Last updated 10 January 2012

What this trial tests

Phase 1 trial testing TC-5214 in Healthy Subjects in 18 participants. Completed in 1 January 2012.

Timeline

1 November 2011

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	18
Start date	1 November 2011
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	1 location across United States

Drugs / interventions tested

TC-5214 — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Subjects. Healthy volunteers can join.

What's being measured

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

TC-5214 area under the plasma concentration time curve will be measured.
Time frame: Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose
TC-5214 maximum plasma concentration will be measured
Time frame: Pre dose, 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 7, 12, 24, 36, 48 and 72 hours post dose

Sponsor's own description

(Food versus no food) crossover study to measure the effects of food on pharmacokinetics of TC-5214 (S-Mecamylamine) in healthy Subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other AstraZeneca trials

Trials by the same sponsor.

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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 NCT01458899 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 10 January 2012

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/NCT01458899.

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