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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-05-10

Brief Summary

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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.

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Detailed Description

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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

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Constipation Drug Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Codeine

Intervention Type DRUG

30mg 4 times daily

naloxegol placebo

Intervention Type DRUG

placebo will match naloxegol, given daily

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.

Group Type PLACEBO_COMPARATOR

Naloxegol

Intervention Type DRUG

25mg daily

codeine placebo

Intervention Type DRUG

4 times daily (placebo will be made to match the codeine)

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.

Group Type ACTIVE_COMPARATOR

Naloxegol

Intervention Type DRUG

25mg daily

Codeine

Intervention Type DRUG

30mg 4 times daily

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.

Group Type ACTIVE_COMPARATOR

codeine placebo

Intervention Type DRUG

4 times daily (placebo will be made to match the codeine)

naloxegol placebo

Intervention Type DRUG

placebo will match naloxegol, given daily

Interventions

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Naloxegol

25mg daily

Intervention Type DRUG

Codeine

30mg 4 times daily

Intervention Type DRUG

codeine placebo

4 times daily (placebo will be made to match the codeine)

Intervention Type DRUG

naloxegol placebo

placebo will match naloxegol, given daily

Intervention Type DRUG

Other Intervention Names

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MOVANTIK

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes