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OpenTrials
Completed

NCT Number: NCT00547014

First Safety Study in Humans of a Single Dose of CPG 52364

Determine the safety and tolerability of the study drug, CPG 52364, when given as liquid or capsule. Another purpose is to determine how the drug enters and leaves the blood stream and body tissues over time.

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Key information

Conditions

Healthy Volunteers Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal body mass index and weight
  • No significant diseases in the medical history or clinically significant findings on physical exam, opthalmologic exam, clinical laboratory evaluations or 12-lead electrocardiogram

Exclusion criteria

  • Current illness or history of medical condition affecting the body's function
  • Use of any medication within 7 days, any immunosuppressive medication within 6 months, any investigational drug within 30 days or any vaccine or immunoglobulin within 90 days
  • Use of any medications during the study
  • Positive TB test
  • Smoking within 6 months
  • Pregnancy or risk of Pregnancy
  • Alcohol or drug misuse within 60 days
  • Sensitivity to quinazolines

Treatment and study plan

Placebo Comparator: Cohort 1 Placebo

Drug

Drug: placebo for cohort 1 as single dose

52364 3 mg

Drug

3 mg capsule single dose administered orally as a single dose

Placebo Comparator: Cohorts 2, 3, 4 & 5 Two subjects each arm will be assigned to receive placebo

Drug

Drug: Placebo for cohorts 2, 3, 4 and 5 administered as a single dose

52364 10 mg

Drug

Drug: 52364 30 mg capsule as a single dose

52364 30 mg

Drug

Drug: 52364 30 mg capsule administered as a single dose

52364 100 mg

Drug

Drug 52364 100 mg capsule administered as a single dose

52364 1 mg

Drug

1 mg powder diluted in liquid or placebo (liquid alone) administered orally as a single dose

Primary outcomes

  1. Clinical Assessment of Adverse Events

    Time frame: 28 days/subject

Secondary outcomes

  1. Pharmacokinetic Parameters

    Time frame: 28 days/subject

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Oral Administration Of CPG 52364 In Healthy Subjects: A Phase 1, Within-Cohort Randomized, Double-Blinded, Placebo-Controlled, Ascending Single-Dose, Single-Center Study

Important dates

Study start
2007
Study completion
2008
First posted
Oct 19, 2007
Registry last updated
Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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