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HealthyPhase 1/2NCT01094821

Effect of ATI-7505 on Gastrointestinal Transit in Healthy Volunteers

A Phase 1/2 study testing ATI-7505 in people with Healthy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ATI-7505
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited States
Study dates
Jan 2005to Dec 2005
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Effect of ATI-7505 on Gastric Emptying and Small Bowel and Colonic Transit in Healthy Volunteers

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.

Read the detailed description

ATI-7505, is an engineered analog of the 5-HT4 agent, cisapride. The objectives of this study are to compare effects of ATI-7505 and placebo on gastric, small bowel and colonic transit in healthy human volunteers and evaluate the safety and tolerability of ATI-7505.

This trial is a double-blind, randomized, placebo-controlled study evaluating the gastrointestinal transit effects of ATI-7505 and placebo. Three different doses (3, 10, 30mg) of ATI-7505 and placebo will be administered in parallel to four independent groups of 12 subjects each. The maximum duration of drug exposure for any subject is 9 days.

All participants will undergo a standard 48 hour gastrointestinal transit measurement using scintigraphy with standardized meals during the first 12 hours. The response endpoints (colonic geometric center at 4 h, colonic geometric center at 24 h, colonic geometric center at 48 h, gastric residual at 2 \& 4 h, colonic filling at 6 h and ascending colonic emptying t1/2) will be based on abdominal scintigraphic images following the technetium-99m egg meal and methacrylate-coated, delayed-release capsule containing 111In labeled activated charcoal.

Safety and tolerability will be evaluated by serial assessment of vital signs, physical examination, ECG, adverse events, concomitant medications and blood sample analysis.

Conditions
Healthy
Being tested
ATI-7505, Placebo
Keywords
Healthy volunteers, ATI-7505, Scintigraphy, Gastrointestinal transit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATI-7505Drug

    3 mg three times daily for 9 days

  • PlaceboDrug

    Placebo capsule three times daily for 9 days

  • ATI-7505Drug

    10 mg ATI-7505 three times daily for 9 days

  • ATI-7505Drug

    20 mg ATI-7505 three times daily for 9 days

Study groups in NCT01094821
Study groupRoleWhat they receive
3 mg ATI-7505Experimental3 mg ATI-7505 three times daily for 9 days followed by transit scintigraphy
Receives: Drug: ATI-7505
PlaceboPlacebo comparatorPlacebo capsule three times daily for 9 days followed by transit scintigraphy
Receives: Drug: Placebo
10 mg ATI-7505Experimental10 mg ATI-7505 three times daily for 9 days followed by transit scintigraphy
Receives: Drug: ATI-7505
20 mg ATI-7505Experimental20 mg ATI-7505 three times daily for 9 days followed by transit scintigraphy
Receives: Drug: ATI-7505

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours

  2. Ascending colonic emptying t1/2

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

    Measured: 24 hours

  3. Gastric emptying of solids (T1/2)

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

    Measured: 4 hours

Secondary outcomes (3)

  1. Colonic filling at 6 h

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

    Measured: 6 hours

  2. Colonic geometric center at 48 hours

    As measured with scintigraphic method following ingestion of In111 capsule and Tc99 labeled breakfast

    Measured: 48 hours

  3. Percent gastric emptying at 1, 2 and 4 hours

    As measured with scintigraphic method following ingestion of 99Tc labeled egg breakfast

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2010 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01094821
Sponsor's protocol ID
IRB 276-05
Other IDs
IND 68,208
Status last verified
Mar 2010
First submitted
4 Aug 2009
Last updated
29 Mar 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17187586

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ATI-7505 in people with Healthy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colonic geometric center at 24 h (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01094821, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2010.

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