A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers

February 1, 2011 updated by: Pulmagen Therapeutics

A Double-Blind Randomized, Placebo-Controlled, Dose Escalating Study to Assess The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ADC3680B Administered Orally to Healthy Volunteers and to Investigate Food Effects on Pharmacokinetics After Single Oral Doses of ADC3680B

This is a First-In-Man study designed to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B after single and multiple doses in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 18 to 30 kg/m2
  • Signed and dated written informed consent prior to admission into the study
  • Willing and able to comply with the requirements of the protocol and available to complete the study

Exclusion Criteria:

  • Evidence of history of any clinically significant medical disorder
  • History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: ADC3680B vs. Placebo
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B or Placebo for 7 days
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Experimental: Cohort 2: ADC3680B vs. Placebo
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B or Placebo for 7 days
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Experimental: Cohort 3: ADC3680B vs Placebo
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B or Placebo for 7 days
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Experimental: Cohort 4: ADC3680B vs. Placebo
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B or Placebo for 7 days
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Experimental: Cohort 5: ADC3680B vs. Placebo
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B or Placebo for 7 days
Single doses ADC3680B over 2 study periods under fasted and fed conditions
Experimental: Cohort 6: ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
ADC3680B or Placebo for 7 days
Single doses ADC3680B over 2 study periods under fasted and fed conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Time Frame: 2 days
2 days
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
Time Frame: 8 days
8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Single dose pharmacokinetics of ADC3680B
Time Frame: 2 days
2 days
Multiple dose pharmacokinetic of ADC3680B
Time Frame: 8 days
8 days
Pharmacokinetics of ADC3680B under fasted and fed conditions
Time Frame: 2 days
2 days
Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo
Time Frame: Pre-dose and up to 48 hours post-dose
Pre-dose and up to 48 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Febbraro, Simbec Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 29, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • ADC3680-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on ADC3680B

3
Subscribe