CompletedNCT02737059Updated Aug 30, 2017

Effect of Naloxegol on Gastric, Small Bowel, and Colonic Transit in Healthy Subjects

A Phase 1 interventional study of Naloxegol and Codeine in Constipation Drug Induced, sponsored by Michael Camilleri. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Michael Camilleri · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was May 2017, 9 years 4 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine.

The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.

Read the detailed description

This was a single center, randomized, double-blind, placebo-controlled, parallel-group, Phase I study of the effects of naloxegol, a novel mu-opioid antagonist, on gastrointestinal and colonic transit in the presence or absence of the mu-opiate, codeine. There is a need to develop effective medications for the treatment of opiate-induced constipation and other motility disorders. Currently available opiates are complicated by addictive potential and induction of troublesome constipation.

Conditions studied

Constipation Drug Induced

Browse trials for

Constipation 1,018

In context

Constipation

1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.

This study's enrollment of 72 is close to the median of 80 across 850 interventional studies indexed under Constipation.

Browse Constipation studies →

Lead sponsor

Michael Camilleri is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Body Mass Index (BMI) between 19 and 30 kg/m\^2 and absolute weight between 45 and 100 kg. for both males and females.
Females who are non-pregnant, non-lactating, postmenopausal for at least one year (as evidenced by last menses 12 months from Day 0), surgically sterile, or willing to use a clinically-approved method of contraception from 35 days prior to Day 0 until 30 days after the last dose of study medication
Males who are surgically sterile or willing to use a clinically approved method of contraception from Day 0 until 30 days after the last dose of study medication.
Absence of gastrointestinal symptoms unless deemed not clinically significant by the Investigator.
Able to understand and willing to sign informed consent
Negative urine drug screen at screening

Exclusion criteria

Exclusion criteria:

Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening, three or more "YES" responses on the Bowel Disease Questionnaire will be used to exclude subjects with irritable bowel syndrome.
Use of drugs or agents within the past 2 weeks or planned use in the subsequent 4 weeks during the study period that: Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetic, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, Selective serotonin re-uptake inhibitors (SSRI) and newer antidepressants.
Analgesic drugs including opiates, NSAID, cyclooxygenase-2 (COX 2) inhibitors
Use of non-prescription or prescription medications within 7 days or within five half-lives prior to Day 0 for that particular medication. Note: Low stable doses of thyroid replacement, estrogen replacement, and birth control pills or depot injections, and use of acetaminophen on as needed basis are permissible.
A score of greater than or equal to 11 for either score obtained from the Hospital Anxiety Depression Scale
Positive urine drug screen at screening
Female subjects who are pregnant or breast feeding.
Clinical evidence (including physical exam, previous laboratory tests) or significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Patients with previously high transaminase levels (AST, ALT) may be retested and if the results are less than 1.5 times the upper limit of normal will be included as long as they do not have an underlying known liver disease.
Symptoms of a significant clinical illness in the preceding two weeks.
Participation in another clinical study within the past 30 days.
Subjects known allergy or hypersensitive to multiple drug compounds (greater than or equal to 3 drug compounds), naloxegol or opioid antagonists, codeine sulfate, eggs or any components of the study medication
Daily use of any tobacco products within 6 months prior to Day 0
Previous exposure to naloxegol
Any other conditions or prior therapy which, in the opinion of the Investigator, would make the subject unsuitable for this study
Contraindications to use of naloxegol in accordance with FDA guidance: suspected GI obstruction or at increased risk of recurrent obstruction; concomitant use of strong CYP3A4 inhibitors such as clarithromycin and ketoconazole
Concomitant treatment with moderate CYP3A4 inhibitors (diltiazem, erythromycin, verapamil) or strong CYP3A4 inducers (rifampin) or other opioid antagonists.
History of substance abuse.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 72 participants (actual)

Study arms

Placebo comparator
Codeine/naloxegol placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement. Codeine tablet 30 mg q.i.d., and placebo tablet matching naloxegol q.d.
Drug: Codeine · Drug: naloxegol placebo
Placebo comparator
Naloxegol/ codeine placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement. Naloxegol tablet 25 mg q.d and placebo tablet matching codeine q.i.d.
Drug: Naloxegol · Drug: codeine placebo
Active comparator
Codeine/ naloxegol
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement. Codeine tablet 30 mg q.i.d., and naloxegol tablet 25 mg q.d.
Drug: Naloxegol · Drug: Codeine
Active comparator
codeine placebo/ naloxegol placebo
Each subject will receive two medications to which they are randomized for 1 day before and for the 2 days during transit measurement. Placebo tablet matching codeine q.i.d., and placebo tablet matching naloxegol q.d.
Drug: codeine placebo · Drug: naloxegol placebo

Interventions

DrugNaloxegol
25mg daily
Also known as: MOVANTIK
DrugCodeine
30mg 4 times daily
Drugcodeine placebo
4 times daily (placebo will be made to match the codeine)
Drugnaloxegol placebo
placebo will match naloxegol, given daily

What researchers measure

Primary outcomes

Gastric emptying (t1/2)
The time for half of the ingested solids or liquids to leave the stomach.
Time frame: Day 2
Colonic filling (%) at 6 hours
Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Time frame: Day 2 (6 hours)
Colonic geometric center (GC) at 24 hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Time frame: Day 2 ( 24 hours)

Secondary outcomes

Colonic transit summarized by GC at 48 hours hours hours colonic transit summarized by GC at 4 and 48 hours Colonic transit at 4 and 48 hours
The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Time frame: Day 2 (48 hours)
Ascending Colon Emptying (ACE) T1/2
Ascending colon emptying half-time will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Time frame: Day 2

Study locations

1 site

Mayo Clinic in Rochester
Rochester, Minnesota 55905, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02737059
Lead sponsor: Michael Camilleri
Collaborators: AstraZeneca
Responsible party: Michael Camilleri (MD, Consultant, Professor of Medicine, Mayo Clinic) — Sponsor-investigator
First posted: Apr 13, 2016
Start date: Jul 1, 2016
Primary completion: May 10, 2017
Completion: May 10, 2017
Last update: Aug 30, 2017

Study contacts

Michael Camilleri, MD

principal investigator · Mayo Clinic

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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