HealthyPhase 1NCT00768183

Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water

A Phase 1 study testing KADIAN Capsule + alcohol (under fasting conditions), KADIAN Capsule + water (under fasting conditions) and morphine sulfate IR oral solution + water in people with Healthy, run by Actavis Inc. 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

The objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules when dosed with alcohol under fasting and fed conditions compared to water. Read more about this study

Who is it for?: Ages 21 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: KADIAN Capsule + alcohol (under fasting conditions), KADIAN Capsule + water (under fasting conditions) and morphine sulfate IR oral solution + water
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: May 2006to Jul 2006
Phase: Phase 1
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 21 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male volunteers, 21 to 40 years of age.
Subjects were non-smokers for at least 3 months or light smokers (less than 10 pack-years).
Subjects with a history of moderate consumption of at least 7-21 units of alcohol per week or the alcohol equivalent (12 oz beer = 5 oz of 80-proof distilled spirits = 1 unit).
Weighing at least 70 kg and within 20% of their ideal weights (table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
Medically healthy subjects with no clinically significant abnormalities in their laboratory profile and ECGs, as deemed by the Principal Investigator.
Voluntarily consented to participate in the study.

Who cannot join

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, history or presence of: alcoholism or drug abuse; asthma or other chronic respiratory illness; diabetes; gastrointestinal dysmotility, irritable bowel syndrome, chronic constipation or recent enteritis; hypersensitivity or idiosyncratic reaction to morphine or other opioids; hypersensitivity or idiosyncratic reaction to naltrexone, naloxone, or other opioids antagonists.
History of no alcohol intake (alcohol-naive) or less than moderate alcohol intake.
Subject with a history of alcohol intake exceeding the equivalence of 21 units/week or exceeding the average of 3 drinks per day.
Subjects who had a surgery of the gastrointestinal tract (except appendectomy) which would interfere with absorption of the study drug.
Subjects who received hepatic enzyme inducing drugs (e.g. Nizoral, Tagamet) within the previous three months.

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Subjects whose QTc interval was >450 msec at screening and prior to dosing.
Subjects whose sitting blood pressure was less than 110/45 mm Hg at screening or 100/45 mm Hg before dosing.
Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
Subjects who had made any significant donation or loss of blood within 56 days.
Subjects who had made a plasma donation within 7 days prior to the study.
Subjects with hemoglobin less than 12.0 g/dL.
Subjects who had participated in another clinical trial within 28 days prior to the first dose.
Subjects who had a positive urine test for drugs of abuse or alcohol.
Subjects who had a positive test for, or had been treated for hepatitis B, hepatitis C or HIV.

Trial locations and contacts

1 site in 1 country.

United States1 site

MDS Pharma Services
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: Phase 1, Single-Center, Open-label, Drug Interaction Study to Evaluate the Effect of Alcohol on the PK of Morphine Sulfate ER (KADIAN) Capsules in Healthy Adults Under Fasting and Fed Conditions and Relative BA to Morphine Solution

Read the detailed description

This study was to evaluate the effect of consumming alcohol on the pharmacokie and bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules under fasting and fed conditions.

In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was assessed for informational purposes and for possible modeling.

Conditions: Healthy
Being tested: KADIAN Capsule + alcohol (under fasting conditions), KADIAN Capsule + water (under fasting conditions), morphine sulfate IR oral solution + water, KADIAN Capsule + alcohol (under fed conditions)
Keywords: KADIAN, morphine, alcohol, water, solution, fed, fasting
Medical subject headings: Lecithin Cholesterol Acyltransferase Deficiency, Fasting

What participants receive

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

KADIAN Capsule + alcohol (under fasting conditions)Drug
Also called Kadian
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL
KADIAN Capsule + water (under fasting conditions)Drug
Also called Kadian
Capsules 100mg + 240 mL in 4 shots of 60 mL
morphine sulfate IR oral solution + waterDrug
Also called Morphine sulfate
Morphine sulfate IR oral solution + water (under fasting conditions)
KADIAN Capsule + alcohol (under fed conditions)Drug
Also called Kadian
Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

Study groups in NCT00768183
Study group	Role	What they receive
Regimen A	Experimental	KADIAN Capsule + alcohol (under fasting conditions) Receives: Drug: KADIAN Capsule + alcohol (under fasting conditions)
Regimen B	Experimental	KADIAN Capsule + alcohol (under fed conditions) Receives: Drug: KADIAN Capsule + alcohol (under fed conditions)
Regimen C	Experimental	KADIAN Capsule + water (under fasting conditions) Receives: Drug: KADIAN Capsule + water (under fasting conditions)
Regimen D	Experimental	Morphine sulfate IR oral solution + water (under fasting conditions) Receives: Drug: morphine sulfate IR oral solution + water

What is being measured

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

To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN
Measured: up to 48 hours post dosing

Secondary outcomes (1)

To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose
Measured: up to 24 hours post dosing

Timeline

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

May 2006Jul 2006

First posted7 Oct 2008 (estimated)
Study startMay 2006
Primary completionJul 2006
Study completionJul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00768183
Sponsor's protocol ID: AA33687
Status last verified: Jul 2020
First submitted: 3 Oct 2008
Last updated: 16 Jul 2020
Results posted: No
Data monitoring committee: No

Publications

Johnson F, Wagner G, Sun S, Stauffer J. Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules. J Pain. 2008 Apr;9(4):330-6. doi: 10.1016/j.jpain.2007.11.009. Epub 2008 Jan 16.
PubMed 18201934

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Single-Center, Open-label, Drug Interaction Study to Evaluate the Effect of Alcohol on the PK of Morphine Sulfate ER (KADIAN) Capsules in Healthy Adults Under Fasting and Fed Conditions and Relative BA to Morphine Solution
ClinicalTrials.gov ID: NCT00768183
Acronym / sponsor ID: AA33687
Conditions: Healthy
Keywords: KADIAN, morphine, alcohol, water, solution, fed, fasting
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Actavis Inc.Industry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 7 Oct 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was assessed for informational purposes and for possible modeling.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Regimen A	Experimental	Drug: KADIAN Capsule + alcohol (under fasting conditions)KADIAN Capsule + alcohol (under fasting conditions)
Regimen B	Experimental	Drug: KADIAN Capsule + alcohol (under fed conditions)KADIAN Capsule + alcohol (under fed conditions)
Regimen C	Experimental	Drug: KADIAN Capsule + water (under fasting conditions)KADIAN Capsule + water (under fasting conditions)
Regimen D	Experimental	Drug: morphine sulfate IR oral solution + waterMorphine sulfate IR oral solution + water (under fasting conditions)

Who may qualify

Ages: 21 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy adult male volunteers, 21 to 40 years of age.
Subjects were non-smokers for at least 3 months or light smokers (less than 10 pack-years).
Subjects with a history of moderate consumption of at least 7-21 units of alcohol per week or the alcohol equivalent (12 oz beer = 5 oz of 80-proof distilled spirits = 1 unit).
Weighing at least 70 kg and within 20% of their ideal weights (table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
Medically healthy subjects with no clinically significant abnormalities in their laboratory profile and ECGs, as deemed by the Principal Investigator.

Key exclusion criteria (15 listed)

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
In addition, history or presence of: alcoholism or drug abuse; asthma or other chronic respiratory illness; diabetes; gastrointestinal dysmotility, irritable bowel syndrome, chronic constipation or recent enteritis; hypersensitivity or idiosyncratic reaction to morphine or other opioids; hypersensitivity or idiosyncratic reaction to naltrexone, naloxone, or other opioids antagonists.
History of no alcohol intake (alcohol-naive) or less than moderate alcohol intake.
Subject with a history of alcohol intake exceeding the equivalence of 21 units/week or exceeding the average of 3 drinks per day.
Subjects who had a surgery of the gastrointestinal tract (except appendectomy) which would interfere with absorption of the study drug.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KADIAN Capsule + alcohol (under fasting conditions)Also: KadianCapsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL	Drug	Regimen A
KADIAN Capsule + water (under fasting conditions)Also: KadianCapsules 100mg + 240 mL in 4 shots of 60 mL	Drug	Regimen C
morphine sulfate IR oral solution + waterAlso: Morphine sulfateMorphine sulfate IR oral solution + water (under fasting conditions)	Drug	Regimen D
KADIAN Capsule + alcohol (under fed conditions)Also: KadianCapsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL	Drug	Regimen B

Primary outcome

To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN
Time frame: up to 48 hours post dosing

1 secondary outcome

To evaluate the pharmacokinetics assessment of an immediate release morphine solution following a 20 mg dose
Time frame: up to 24 hours post dosing

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
Results publication: PubMed 18201934Johnson F, Wagner G, Sun S, Stauffer J. Effect of concomitant ingestion of alcohol on the in vivo pharmacokinetics of KADIAN (morphine sulfate extended-release) capsules. J Pain. 2008 Apr;9(4):330-6. doi: 10.1016/j.jpain.2007.11.009. Epub 2008 Jan 16.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James C Kisicki, MD principal investigator

MDS Pharma Services

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 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 16 Jul 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

To evaluate the effect of alcohol ingestion on the pharmacokinetics of KADIAN (time frame: up to 48 hours post dosing). 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 NCT00768183, 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 16 Jul 2020.