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

This study has been completed.

Sponsor:

Information provided by:

Pulmagen Therapeutics

ClinicalTrials.gov Identifier:

NCT01173770

First received: July 29, 2010

Last updated: February 1, 2011

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2010

Last Updated Date

February 1, 2011

Start Date ^ICMJE

July 2010

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01173770 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Single dose pharmacokinetics of ADC3680B [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Multiple dose pharmacokinetic of ADC3680B [ Time Frame: 8 days ] [ Designated as safety issue: No ]
Pharmacokinetics of ADC3680B under fasted and fed conditions [ Time Frame: 2 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
Drug: ADC3680B
ADC3680B or Placebo for 7 days
Drug: ADC3680B
Single doses ADC3680B over 2 study periods under fasted and fed conditions

Study Arm (s)

Experimental: Cohort 1: ADC3680B vs. Placebo
Intervention: Drug: ADC3680B
Experimental: Cohort 2: ADC3680B vs. Placebo
Intervention: Drug: ADC3680B
Experimental: Cohort 3: ADC3680B vs Placebo
Intervention: Drug: ADC3680B
Experimental: Cohort 4: ADC3680B vs. Placebo
Intervention: Drug: ADC3680B
Experimental: Cohort 5: ADC3680B vs. Placebo
Intervention: Drug: ADC3680B
Experimental: Cohort 6: ADC3680B
Intervention: Drug: ADC3680B

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01173770

Other Study ID Numbers ^ICMJE

ADC3680-01

Has Data Monitoring Committee

Responsible Party

Dr Salvatore Febbraro, Simbec Research Limited

Study Sponsor ^ICMJE

Pulmagen Therapeutics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Febbraro

Simbec Research

Information Provided By

Pulmagen Therapeutics

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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