Effect of ATI-7505 on Gastrointestinal Transit in Healthy Volunteers

NCT01094821 | Completed Phase 1

• 2 other identifiers: IRB 276-05IND 68,208
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pharmacodynamic study in healthy volunteers to determine the effects of a new 5-HT4 agonist on gastric, small bowel and colonic transit.

Conditions

Healthy

Keywords

Healthy volunteers; ATI-7505; Scintigraphy; Gastrointestinal transit

Outcome Measures

Primary Outcomes (3)

• Colonic geometric center at 24 h

  Colonic geometric center determined 24 hours post first camera image following ingestion of study medication with Indium-111 capsule and breakfast with Technetium-99 labeled egg breakfast

  24 hours

• Ascending colonic emptying t1/2

  As measured with scintigraphic method following 111In labeled capsule and 99Tc labeled egg breakfast

  24 hours

• Gastric emptying of solids (T1/2)

  As measured with scintigraphic method following technetium-99m egg meal

  4 hours

Secondary Outcomes (3)

• Colonic filling at 6 h

  6 hours

• Colonic geometric center at 48 hours

  48 hours

• Percent gastric emptying at 1, 2 and 4 hours

  4 hours

Study Arms (4)

3 mg ATI-7505

EXPERIMENTAL

3 mg ATI-7505 three times daily for 9 days followed by transit scintigraphy

Drug: ATI-7505

Placebo

PLACEBO COMPARATOR

Placebo capsule three times daily for 9 days followed by transit scintigraphy

Drug: Placebo

10 mg ATI-7505

EXPERIMENTAL

10 mg ATI-7505 three times daily for 9 days followed by transit scintigraphy

Drug: ATI-7505

20 mg ATI-7505

EXPERIMENTAL

20 mg ATI-7505 three times daily for 9 days followed by transit scintigraphy

Drug: ATI-7505

Interventions

ATI-7505 DRUG

3 mg three times daily for 9 days

3 mg ATI-7505

Placebo DRUG

Placebo capsule three times daily for 9 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers between the ages of 18 to 65 years old (inclusive) with a BMI \≥ 18 and \≤ 32
• PR, QRS and QT intervals within normal limits on screening ECG. Specifically, PR \< 220 msec, QRS \< 140 msec, QTc \< 450 msec
• Are able and willing to understand study requirements, follow instructions, attend all required study visits (especially during 48 hrs of scintigraphic scan), undergo all planned tests (including drawing of blood samples and consumption of standardized study meals)
• Are able and willing to sign IRB-approved, written informed consent to participate in this study
• Have had negative urine screen and clinical history (prior 2 years) for drugs of abuse at screening visit
• Women with no child bearing potential, as defined by at least 1 year post-menopausal (absence of vaginal bleeding or spotting) or surgically sterile. Men will have a sterile sexual partner or will, starting at time of study drug administration a minimum of 1 month after study drug administration, be willing to use an approved method of contraception (which may include use of a condom with spermicide or use by partner of oral, implantable or injectable contraceptives, IUD, diaphragm with spermicide)

You may not qualify if:

• Inability to understand study requirements or follow study procedures (especially entire 48 h of scintigraphy examination), attend all required study visits, undergo all planned tests (including drawing of blood samples and consumption of study meals)
• Any out of range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant (NCS) by the Principal Investigator.
• Use of alcohol within 24 h of randomization visit (Visit 2) and through completion of the study
• History of untoward effects of metoclopramide
• Any clinically significant abnormality on screening ECG.
• Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Principal Investigator, would make the subject unsuitable for the study or put them at additional risk)
• Known allergy, hypersensitivity or sensitivity to cisapride
• Pregnancy or lactation
• History of alcohol or other substance abuse within the past two years
• Received treatment with any other investigational drug within the preceding 30 days or 5 half-lives, whichever is greater
• Major surgery within 3 months of study entry and any surgery within 2 weeks of study entry unless approved by the Principal Investigator and Sponsor?s Medical Monitor
• Any documented history of irregular intestinal transit including but not limited to gastro-esophageal reflux disease (GERD), gastroparesis of any kind, irritable bowel syndrome, inflammatory bowel disease and chronic constipation or diarrhea under the care of a physician and/or requiring daily medication
• Any history of gastrointestinal tract or abdominal surgery, except tubal ligation, hysterectomy, appendectomy, cholecystectomy or hemorrhoid surgery \> 3 months prior to screening
• More than three positive (i.e., ?yes?) responses on screening bowel symptom questionnaire

Sponsors & Collaborators

• Mayo Clinic: lead
• ARYx Therapeutics: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Camilleri M, Vazquez-Roque MI, Burton D, Ford T, McKinzie S, Zinsmeister AR, Druzgala P. Pharmacodynamic effects of a novel prokinetic 5-HT receptor agonist, ATI-7505, in humans. Neurogastroenterol Motil. 2007 Jan;19(1):30-8. doi: 10.1111/j.1365-2982.2006.00865.x.

  PMID: 17187586 RESULT

MeSH Terms

Interventions

ATI 7505

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: March 29, 2010
• Study Start: January 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: March 29, 2010

Record last verified: 2010-03

Locations

US (1)