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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173770
• Other study ID #: ADC3680-01
• Status: Completed
• Phase: Phase 1
• First received: July 29, 2010
• Last updated: February 1, 2011
• Start date: July 2010
• Est. completion date: February 2011

Study information

• Verified date: July 2010
• Source: Pulmagen Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Simbec	Merthyr Tydfil

Sponsors (1)

Lead Sponsor	Collaborator
Pulmagen Therapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs		2 days	Yes
Primary	Safety and tolerability of multiple doses of ADC3680B determined by adverse event reporting, clinical laboratory tests, vital signs and ECGs		8 days	Yes
Secondary	Single dose pharmacokinetics of ADC3680B		2 days	No
Secondary	Multiple dose pharmacokinetic of ADC3680B		8 days	No
Secondary	Pharmacokinetics of ADC3680B under fasted and fed conditions		2 days	No
Secondary	Eosinophil shape change in response to stimulation with PGD2 in whole blood ex vivo		Pre-dose and up to 48 hours post-dose	No