- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173770
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
Intervention / Treatment
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
-
-
-
Merthyr Tydfil, United Kingdom, CF48 4DR
- Simbec
-
-
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.
Sponsor
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.
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