A Study to Assess the Bioavailability of ASP015K

NCT01430078 | Completed Phase 1

• 2 other identifiers: 015K-CL-PK152010-021160-15
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess the bioavailability of ASP015K within the gastrointestinal tract.

Conditions

Healthy

Keywords

ASP015K; Healthy subjects; Pharmacokinetics of ASP015K

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic assessment of AUC through the analysis of blood samples

  Up to 45 days

Secondary Outcomes (1)

• Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples

  Up to 45 days

Study Arms (4)

Regimen A

EXPERIMENTAL

ASP015K oral tablet

Drug: ASP015K

Regimen B

EXPERIMENTAL

ASP015K solution delivered to distal small bowel via oral capsule

Drug: ASP015K

Regimen C

EXPERIMENTAL

ASP015K solution delivered to ascending colon via oral capsule

Drug: ASP015K

Regimen D

EXPERIMENTAL

ASP015K solution delivered to distal transverse colon via oral capsule

Drug: ASP015K

Interventions

ASP015K DRUG

oral tablet

Regimen A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject weighing at least 45 kg and BMI of 18-32 kg/m2
• Subject must demonstrate their ability to swallow an empty size 000 capsule
• Subject agrees to sexual abstinence, is surgically sterile (with documentation provided by a healthcare professional), or is using a medically acceptable method to prevent pregnancy during the study
• Subject has a normal 12-lead ECG
• Subject is medically healthy, with no clinically significant medical history or abnormalities

You may not qualify if:

• Subject has ever sought advice from, or been referred to, a General Practitioner (GP) or counselor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents
• Subject is currently using or has had previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines
• The subject has a positive drugs of abuse test result
• The subject regularly consumes alcohol \>21 units per week
• The subject is a current smoker or has smoked within the last 12 months
• The subject has clinically significant abnormal biochemistry, hematology or urinalysis
• The subject has a history of gastrointestinal surgery (with the exception of appendectomy unless it was performed within the previous 12 months)
• The subject has a history of clinically significant cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease, especially peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's Disease or Irritable Bowel Syndrome
• The subject has had radiation exposure from clinical trials exceeding 5 mSv in the last twelve months or 10 mSv in the last five years
• The subject has a history of adverse reaction or allergy to study drug or its excipients The subject suffers from hayfever they must not have or be expecting to have symptoms during the study
• The subject has had acute diarrhoea or constipation in the 7 days before the first study day
• The subject has the presence of non-removable metal objects such as metal plates, screws, etc, in the abdominal region of the body (with the exception of sterilisation clips)
• The subject has a positive Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human Immunodeficiency virus HIV results
• The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to study drug administration, or over the counter medication within 7 days prior to study drug administration
• The subject has/had a symptomatic, viral, bacterial, or fungal infection within 1 week prior to clinic check in

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

Quotient Clinical Limited

Ruddington, Nottingham, NG116JS, United Kingdom

Location

MeSH Terms

Interventions

peficitinib

Study Officials

• Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: September 7, 2011
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 7, 2011

Record last verified: 2011-09

Locations

GB (1)