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
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: ADC3680B
Phase 1

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

Further study details as provided by Pulmagen Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 52
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: ADC3680B vs. Placebo Drug: ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
Experimental: Cohort 2: ADC3680B vs. Placebo Drug: ADC3680B
Escalating single doses ADC3680B or Placebo over 5 study periods
Experimental: Cohort 3: ADC3680B vs Placebo Drug: ADC3680B
ADC3680B or Placebo for 7 days
Experimental: Cohort 4: ADC3680B vs. Placebo Drug: ADC3680B
ADC3680B or Placebo for 7 days
Experimental: Cohort 5: ADC3680B vs. Placebo Drug: ADC3680B
ADC3680B or Placebo for 7 days
Experimental: Cohort 6: ADC3680B Drug: ADC3680B
Single doses ADC3680B over 2 study periods under fasted and fed conditions

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173770

Locations
United Kingdom
Simbec
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Pulmagen Therapeutics
Investigators
Principal Investigator: Febbraro Simbec Research
  More Information

No publications provided

Responsible Party: Dr Salvatore Febbraro, Simbec Research Limited
ClinicalTrials.gov Identifier: NCT01173770     History of Changes
Other Study ID Numbers: ADC3680-01
Study First Received: July 29, 2010
Last Updated: February 1, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on July 29, 2014