NCT00994591

Brief Summary

Levels of cotinine, a biomarker for nicotine, have been found to be higher in infants and small children than adults. This pharmacokinetic study is designed to determine whether children metabolize cotinine differently than adults. Seventy-two healthy children between the ages of 2 months and 6 years will come with their mothers to SFGH GCRC for one approximately 9 hour visit. After being examined by a pediatrician, the child will be administered one dose of cotinine at .05 mg/kg. Saliva and urine samples will be collected prior to dosing and throughout the day to characterize the metabolism and excretion of cotinine. The investigators have previously shown that a ratio of 3'-hydroxycotinine/cotinine (3HC/Cot) in saliva correlates closely to nicotine metabolism. Following these one day hospital visits, a research assistant will visit the participants in their homes to collect urine and saliva samples at 1,2,3,7, and 10 days after the initial dose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

4.4 years

First QC Date

October 6, 2009

Last Update Submit

May 23, 2013

Conditions

Secondhand Smoke Exposure

Keywords

NicotineCotinineCYP2A6

Outcome Measures

Primary Outcomes (1)

  • Cotinine clearance

    8 hours

Secondary Outcomes (1)

  • Half-life of cotinine

    8 hour

Study Arms (1)

Pharmacokinetic dosing

EXPERIMENTAL
Drug: Pharmacokinetic dosing

Interventions

Pharmacokinetic dosingDRUG

Pharmacokinetic testing involves dosing with deuterated cotinine which has an associated IND#61329.

Pharmacokinetic dosing

Eligibility Criteria

Age2 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Ages: 12 months, 13-24 months, and 25-83 months
  • Caucasian (including Hispanic) and African American only
  • Some exposure to secondhand smoke

You may not qualify if:

  • Any medical problems
  • Taking prescription medication (there are exceptions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco, SFGH, CTSI,CRC

San Francisco, California, 94101, United States

Location

Study Officials

  • Neal L Benowitz, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 14, 2009

Study Start

January 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

US(1)