An Open Label Study to Examine the Effect of Coated Nifedipine Suppositories on Anal Pressure in Healthy Subjects

NCT00816205 | Completed Phase 1

• 1 other identifier: RDD102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, dose-finding study. Approximately 8 healthy subjects will be participating in this study. Within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one day treatment period. During this period, 4 anal manometric studies will take place. Study medication (Coated Nifedipine suppositories at various doses) will be administered at pre-determined intervals. During the study, blood samples will be obtained for plasma Nifedipine analysis.

Conditions

Anal Resting Pressure

Outcome Measures

Primary Outcomes (1)

• The primary efficacy parameter is change in Resting Anal Pressure from baseline.

  1 day

Study Arms (1)

Single Arm

EXPERIMENTAL

This is an open label, dose-finding study. After detrminig baseline resting anal pressure with a manometric test, coated Suppositories will be administered intra rectally. Subjects will take rectally a total of 3 Coated Suppositories per study.

Drug: Coated Nifedipine Suppositories

Interventions

Coated Nifedipine Suppositories DRUG

Subjects will take rectally a total of 3 Coated Suppositories per study. 90 minutes after each coated suppository insertion this suppository will be removed and a amnometric study will be performed: The first dose will contain 4 mg of Nifedipine and the manomentric measurement performed afterwards will be used to determine baseline anal pressures. The second dose will contain 12 mg of Nifedipine. The third dose will contain 24 mg of Nifedipine.

Single Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects meeting the following criteria will be eligible to participate in the trial:
• Signed written informed consent;
• Male or female subjects 18 to 55 years of age;

You may not qualify if:

• Subjects are excluded from participation in the study if any of the following criteria apply:
• Has a clinically significant history or presence of any of the following conditions:
• Known allergy to Nifedipine, polyethylene-glycol, Propylene-glycol or silicone.
• Active or past history of disease that requires medication or clinical follow up.
• Malignant disease within 5 years of screening;
• History of ano rectal disease.
• History of gastrointestinal disease.
• History of gastrointestinal bleeding.
• History of rectal surgery.
• History of gastrointestinal surgery.
• History of HIV.
• In need of chronic use of medication, with the exception of birth control medications.
• Currently uses medication for acute illness.
• Has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula., infection or space occupying lesion.
• Has received any investigational drug within 90 days of screening;

Sponsors & Collaborators

• RDD Pharma Ltd: lead

Study Sites (1)

Dept of Gastroeneterology, Asaf Harofe Medical Center

Zrifin, Israel

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 7, 2009

Record last verified: 2009-04

Locations

IL (1)