Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT00751699
• Recruitment Status: Completed
• First Posted: September 12, 2008
• Last Update Posted: April 17, 2013
• Sponsor: Warner Chilcott
• Information provided by (Responsible Party): Warner Chilcott

Tracking Information

• First Submitted Date: September 11, 2008
• First Posted Date: September 12, 2008
• Last Update Posted Date: April 17, 2013
• Study Start Date: March 2007
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 11, 2008): Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda. [ Time Frame: Day 7 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
• Official Title: A Randomized, Open-label, Multiple Dose, Parallel Group Study to Evaluate 5 ASA and N Ac 5 ASA Pharmacokinetics Following Administration of Oral Doses of Asacol 2.4 g/Day and Lialda 2.4 g/Day for 7 Days in Healthy Volunteers
• Brief Summary: This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e [%]) over the 24-hour period on Day 7.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label)
• Condition: Healthy

Intervention

• Drug: Asacol
  Asacol tablets, 6 tablets per day at 7 am for 7 days
• Drug: Asacol
  Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days
• Drug: Lialda
  Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days

Study Arms

• Experimental: 1
  Asacol 6x400 mg Q24h at 7 am for 7 days
  Intervention: Drug: Asacol
• Experimental: 2
  Asacol 2x400 mg Q8h at 7 am, 3 pm, and 11 pm for 7 days
  Intervention: Drug: Asacol
• Experimental: 3
  Lialda 2x1.2g Q24h at 7 am for 7 days
  Intervention: Drug: Lialda

• Publications *: Vande Casteele N, Jakate A, McNamee B, Sandborn WJ. Similar pharmacokinetics of three dosing regimens comprising two oral delayed-release mesalamine formulations in healthy adult volunteers: Randomised, open-label, parallel-group study. Br J Clin Pharmacol. 2020 Jul 15. doi: 10.1111/bcp.14479. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2008): 37
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2007
• Actual Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Males or females between 18 and 45 years of age, inclusive, at screening and in good general health based on medical history, physical examination, and laboratory evaluation;
• If female, must be (as documented by patient reported medical history):
• postmenopausal (at least 1 year without spontaneous menses), or
• surgically sterile (tubal ligation or hysterectomy), or
• using acceptable contraception [e.g., sexual partner with non-reversed vasectomy (with azoospermia in 2 tests), 2 barrier methods (e.g., condom, diaphragm, or spermicide), or intra-uterine device];
• Body mass index (BMI) between 18 and 32 kg/m2, inclusive;
• Able to swallow the assigned study medication tablet whole; and,
• Able to fulfill the requirements of the protocol and provide written informed consent.

Exclusion Criteria:

• History or presence of any condition or gastrointestinal (GI) surgery causing malabsorption or an effect on GI motility;
• Any uncontrolled acute disease or major surgical operation requiring hospitalization within 1 month of screening;
• History of diabetes, syncope, cardiovascular, hepatic, or renal disease;
• Uncontrolled chronic diseases such as hypertension, systemic lupus erythematosus, or rheumatoid arthritis;
• History of cancer within the last 5 years (except for basal cell carcinoma with a documented 6-month remission);
• Any known enzyme-inducer, enzyme-inhibitor, or reported chronic exposure to enzyme-inducers such as paint solvents or pesticides within 30 days of treatment;
• Any prescription drug or herbal remedy within 14 days prior to scheduled dosing

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00751699
• Other Study ID Numbers: 2007011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Warner Chilcott
• Study Sponsor: Warner Chilcott
• Collaborators: Not Provided

Investigators

• Study Director: William S Aronstein, MD, PhD; Procter and Gamble

• PRS Account: Warner Chilcott
• Verification Date: April 2013