A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ADC3680B in Healthy Volunteers
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
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Jul 2010
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 29, 2010
CompletedFirst Posted
Study publicly available on registry
August 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFebruary 2, 2011
July 1, 2010
7 months
July 29, 2010
February 1, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
2 days
Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs
8 days
Secondary Outcomes (4)
Single dose pharmacokinetics of ADC3680B
2 days
Multiple dose pharmacokinetic of ADC3680B
8 days
Pharmacokinetics of ADC3680B under fasted and fed conditions
2 days
Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo
Pre-dose and up to 48 hours post-dose
Study Arms (6)
Cohort 1: ADC3680B vs. Placebo
EXPERIMENTALCohort 2: ADC3680B vs. Placebo
EXPERIMENTALCohort 3: ADC3680B vs Placebo
EXPERIMENTALCohort 4: ADC3680B vs. Placebo
EXPERIMENTALCohort 5: ADC3680B vs. Placebo
EXPERIMENTALCohort 6: ADC3680B
EXPERIMENTALInterventions
Escalating single doses ADC3680B or Placebo over 5 study periods
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of history of any clinically significant medical disorder
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Simbec
Merthyr Tydfil, CF48 4DR, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Febbraro
Simbec Research
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 29, 2010
First Posted
August 2, 2010
Study Start
July 1, 2010
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
February 2, 2011
Record last verified: 2010-07