NCT00164112 is a Phase 4 clinical trial of Cooperstown 5+1 alone in Healthy, sponsored by Bassett Healthcare.

Who is sponsoring NCT00164112?

NCT00164112 is sponsored by Bassett Healthcare.

What drugs are being tested in NCT00164112?

Interventions in NCT00164112: Cooperstown 5+1 alone, Azithromycin plus Cooperstown 5+1, Telithromycin plus Cooperstown 5+1, Levofloxacin plus Cooperstown 5+1.

Is NCT00164112 still recruiting?

NCT00164112 is currently completed. Last updated 13 September 2005.

Last reviewed 2005-09-13 · How we verify

NCT00164112

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

Comparison of the Effect of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes Using the Validated Cooperstown 5+1 Cocktail

Completed Phase 4 Last updated 13 September 2005

What this trial tests

Phase 4 trial testing Cooperstown 5+1 alone in Healthy in 16 participants. Completed in 1 June 2005.

Timeline

1 November 2004

1 June 2005

Quick facts

Lead sponsor	Bassett Healthcare
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	16
Start date	1 November 2004
Estimated completion	1 June 2005

Drugs / interventions tested

Cooperstown 5+1 alone — full drug profile →
Azithromycin plus Cooperstown 5+1 — full drug profile →
Telithromycin plus Cooperstown 5+1 — full drug profile →
Levofloxacin plus Cooperstown 5+1 — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Bassett Healthcare — full company profile →

Who can join

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

What's being measured

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

Phenotype measures

Sponsor's own description

Studies have previously shown that a broad drug interaction screening can be performed using enzyme specific probes such as oral caffeine for CYP1A2, N-acetyltrasferase-2 (NAT-2), and xanthine oxidase (XO), warfarin plus vitamin K for CYP2C9, omeprazole for CYP 2C19, dextromethorphan for CYP2D6, and midazolam for CYP3A4/5. This combination of probes has been validated in the Cooperstown 5+1 Cocktail (5+1).1 The use of the 5+1 cocktail provides information on the drug metabolizing enzymes that metabolize 90% of hepatically eliminated drugs for a fraction of the costs of the individual studies. Using a cocktail of biomarkers reduces the overall cost of drug interaction screening. The purpose of this study is to evaluate the effects of three Food and Drug Administration (FDA) approved oral antibiotics (azithromycin, telithromycin, and levofloxacin) on metabolism of other medications when taken together. This will be determined by the measuring the activity of drug metabolizing enzymes following administration of certain drug probes (caffeine, dextromethorphan, omeprazole, midazolam, and warfarin with vitamin K). A total of 16 subjects will complete four phases of the study: 1) Cooperstown 5+1 alone, 2) Azithromycin plus Cooperstown 5+1, 3) Telithromycin plus Cooperstown 5+1, and 4) Levofloxacin plus Cooperstown 5+1.

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 NCT00164112 (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 Bassett Healthcare
Last refreshed: 13 September 2005

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/NCT00164112.

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