NCT01240967 is a Phase 1 clinical trial of TC-5214 in Healthy Volunteers, sponsored by AstraZeneca.

Who is sponsoring NCT01240967?

NCT01240967 is sponsored by AstraZeneca.

What drugs are being tested in NCT01240967?

Interventions in NCT01240967: TC-5214.

What condition does NCT01240967 study?

NCT01240967 studies Healthy Volunteers, Patients, Pharmacokinetics, Renal Impairment.

Is NCT01240967 still recruiting?

NCT01240967 is currently completed. Last updated 14 March 2014.

Last reviewed 2014-03-14 · How we verify

NCT01240967

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

An Open-Label, Multi-Center, Phase I Study To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 (S-Mecamylamine) in Subjects With Renal Impairment With Subjects With Normal Renal Function

Completed Phase 1 Last updated 14 March 2014

What this trial tests

Phase 1 trial testing TC-5214 in Healthy Volunteers in 40 participants. Completed in 1 July 2011.

Timeline

1 November 2010

Primary endpoint
1 July 2011

1 July 2011

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Masking	none
Enrollment	40
Start date	1 November 2010
Primary completion	1 July 2011
Estimated completion	1 July 2011
Sites	2 locations across United States

Drugs / interventions tested

TC-5214 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Patients — all drugs for Patients →
Pharmacokinetics — all drugs for Pharmacokinetics →
Renal Impairment — all drugs for Renal Impairment →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 80, any sex, with Healthy Volunteers or Patients. Healthy volunteers can join.

What's being measured

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

The pharmacokinetics (PK) of a single dose of TC-5214 in subjects with renal impairment in comparison to the results in subjects with normal renal function
Time frame: For Group 1, Group 2, and Group 3 blood PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose.
The pharmacokinetics (PK) of a single dose of TC-5214 in subjects with renal impairment in comparison to the results in subjects with normal renal function
Time frame: For Group 4 blood PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, and 72 hours postdose.
If study procedures for any subjects in Group 4 are extended by 24 hours to Day 5, PK samples will be collected at predose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose.

Sponsor's own description

The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.

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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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 NCT01240967 (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: 14 March 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/NCT01240967.

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