HealthyPhase 1NCT00637403

Effect of Renal Impairment on the Pharmacokinetics, and Safety of Megestrol Acetate Concentrated Suspension

A Phase 1 study testing Megestrol acetate concentrated suspension 125 mg/mL in people with Healthy, run by Par Pharmaceutical, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To determine the pharmacokinetics and safety of megestrol acetate after a single oral 300 mg dose of megestrol acetate concentrated suspension in healthy subjects, and subjects with varying degrees of renal impairment Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Megestrol acetate concentrated suspension 125 mg/mL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: May 2006to May 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 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy Subjects with Normal Renal Function
BMI ≥18 kg/m2 and ≤35 kg/m2
Females of child-bearing potential must use an adequate and reliable method of contraception. Postmenopausal females must be postmenopausal ≥1 year and have elevated serum FSH
Able to provide written informed consent
Normal renal function, defined as estimated creatinine clearance (CLcr) >80 mL/min at screening
Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD

Show all 13Show fewer

Meet inclusion criteria 1 through 3 for healthy subjects and the following criteria:
Renal impairment defined as creatinine clearance <80 mL/min as determined using the Cockroft-Gault formula. Subjects grouped according to degree of renal dysfunction: mild (CLcr = >50 and ≤80 mL/min), moderate (CLcr = >30 and ≤50 mL/min), or severe (CLcr = ≤30 mL/min)
Renal Impairment subjects must have evidence of stable renal impairment. Defined as having CLcr values within 25% of each other from 2 separately measured serum creatinine clearances using the Cockroft-Gault formula
ESRD subjects require hemodialysis for at least 3 months
Subjects with renal impairment or ESRD may have clinical laboratory test result deviations that are judged by the Investigator to be consistent with the renal condition of the subject or of no additional clinical significance for this study
Subjects with renal impairment or ESRD, must have stable underlying medical conditions for at least 90 days prior to the start of study participation
Renal impaired subjects may smoke up to 5 cigarettes per day

Who cannot join

Healthy Subjects with Normal Renal Function
Clinically significant (history of or active) cardiac, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, hematologic, oncologic, or psychiatric disease that could put the subject at increased risk or could interfere with the objectives of the study
Presence of any screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator
Use of a prescription drug within 14 days of study start, a non-prescription drug within 7 days of study start, or need of concomitant medication during the study
Use of any drugs or herbal products known to inhibit or induce liver enzymes involved in drug metabolism (CYP P450) within 30 days prior to 1st dose
History of allergic reaction or serum sickness to any drug or drug metabolites

Show all 19Show fewer

Whole blood donation within 56 days prior to the first MA-CS dose or plasma donation within 7 days prior to the first MA-CS dose
Positive test for HIV antibody or hepatitis B surface antigen (positive HIV or hepatitis C antibody for ESRD subjects are acceptable)
Presence of drugs of abuse and/or alcohol
Participation in another investigational drug study within 30 days prior to the first MA-CS dose
History of recent drug abuse or alcohol addiction during past 2 years
Pregnant or breastfeeding
Consumption of grapefruit containing foods and beverages within 7 days prior to the first MA-CS dose
History of recurrent thromboembolic events, a thromboembolic event in past three months, or those still receiving long-term anticoagulation for thromboembolism
Subjects with Mild, Moderate, or Severe Renal Impairment or ESRD
Excluded if subjects meet exclusion criteria 4 through 13 for healthy subjects and the following criteria:
Unstable disease defined as concurrent medical conditions that change significantly within 90 days
Changes in concomitant medications within 14 days prior to first dose administration or expected changes during study participation
Subjects with a renal transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

SFBC International
Miami, Florida, 33181

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Assess the Effect of Renal Impairment on the Pharmacokinetic Characteristics, Safety, and Tolerability of Megestrol Acetate

Conditions: Healthy
Being tested: Megestrol acetate concentrated suspension 125 mg/mL
Keywords: renal impairment, end stage renal disease, megestrol acetate, pharmacokinetics, hemodialysis, renal dialysis, kidney failure, chronic, renal insufficiency, Megace ES
Medical subject headings: Renal Insufficiency, Kidney Failure, Chronic

What participants receive

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

Megestrol acetate concentrated suspension 125 mg/mLDrug
Also called Megace ES
Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with normal renal function (CLcr >80 mL/min)
Megestrol acetate concentrated suspension 125 mg/mLDrug
Also called Megace ES
Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with mild renal impairment (CLcr 50 - 80 mL/min)
Megestrol acetate concentrated suspension 125 mg/mLDrug
Also called Megace ES
Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with moderate renal impairment (CLcr 30 - <50 mL/min)
Megestrol acetate concentrated suspension 125 mg/mLDrug
Also called Megace ES
Megestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with severe renal impairment (CLcr <30 mL/min and not on hemodialysis)
Megestrol acetate concentrated suspension 125 mg/mLDrug
Also called Megace ES
Megestrol acetate concentrated suspension (125 mg/mL) administered orally as 2 single doses of 300 mg (2.4 mL x 125 mg/mL) each in subjects with end stage renal disease undergoing hemodialysis. Washout period of 21 days between each dose

Study groups in NCT00637403
Study group	Role	What they receive
I	Active comparator	Megestrol acetate concentrated suspension in subjects with normal renal function Receives: Drug: Megestrol acetate concentrated suspension 125 mg/mL
II	Experimental	Megestrol acetate concentrated suspension in subjects with mild renal impairment Receives: Drug: Megestrol acetate concentrated suspension 125 mg/mL
III	Experimental	Megestrol acetate concentrated suspension in subjects with moderate renal impairment Receives: Drug: Megestrol acetate concentrated suspension 125 mg/mL
IV	Experimental	Megestrol acetate concentrated suspension in subjects with severe renal impairment Receives: Drug: Megestrol acetate concentrated suspension 125 mg/mL
V	Experimental	Megestrol acetate concentrated suspension in subjects with end stage renal disease Receives: Drug: Megestrol acetate concentrated suspension 125 mg/mL

What is being measured

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

Pharmacokinetic blood samples
Measured: predose and serially through 264 hours post dose
Urine collection
Measured: Predose and serially through 264 hours post dose

Timeline

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

May 2006May 2006

First posted18 Mar 2008 (estimated)
Study startMay 2006
Primary completionMay 2006
Study completionMay 2006

Why it stopped: Difficulty finding the required subject population

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00637403
Sponsor's protocol ID: 100.2.C.002
Status last verified: Oct 2016
First submitted: 11 Mar 2008
Last updated: 17 Oct 2016
Results posted: No
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Assess the Effect of Renal Impairment on the Pharmacokinetic Characteristics, Safety, and Tolerability of Megestrol Acetate
ClinicalTrials.gov ID: NCT00637403
Acronym / sponsor ID: 100.2.C.002
Conditions: Healthy
Keywords: renal impairment, end stage renal disease, megestrol acetate, pharmacokinetics, hemodialysis, renal dialysis, kidney failure, chronic, renal insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty finding the required subject population
Enrolment: 7 participants (actual)
Lead sponsor: Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
Collaborators: Covance, SFBC Anapharm
Study start: May 2006
Primary completion: May 2006 (actual)
Study completion: May 2006 (actual)
First posted: 18 Mar 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.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
I	Active comparator	Drug: Megestrol acetate concentrated suspension 125 mg/mLMegestrol acetate concentrated suspension in subjects with normal renal function
II	Experimental	Drug: Megestrol acetate concentrated suspension 125 mg/mLMegestrol acetate concentrated suspension in subjects with mild renal impairment
III	Experimental	Drug: Megestrol acetate concentrated suspension 125 mg/mLMegestrol acetate concentrated suspension in subjects with moderate renal impairment
IV	Experimental	Drug: Megestrol acetate concentrated suspension 125 mg/mLMegestrol acetate concentrated suspension in subjects with severe renal impairment
V	Experimental	Drug: Megestrol acetate concentrated suspension 125 mg/mLMegestrol acetate concentrated suspension in subjects with end stage renal disease

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Healthy Subjects with Normal Renal Function
BMI ≥18 kg/m2 and ≤35 kg/m2
Females of child-bearing potential must use an adequate and reliable method of contraception. Postmenopausal females must be postmenopausal ≥1 year and have elevated serum FSH
Able to provide written informed consent
Normal renal function, defined as estimated creatinine clearance (CLcr) >80 mL/min at screening

Key exclusion criteria (19 listed)

Healthy Subjects with Normal Renal Function
Clinically significant (history of or active) cardiac, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, hematologic, oncologic, or psychiatric disease that could put the subject at increased risk or could interfere with the objectives of the study
Presence of any screening laboratory values outside the range of normal values and deemed clinically significant by the Investigator
Use of a prescription drug within 14 days of study start, a non-prescription drug within 7 days of study start, or need of concomitant medication during the study
Use of any drugs or herbal products known to inhibit or induce liver enzymes involved in drug metabolism (CYP P450) within 30 days prior to 1st dose

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
Megestrol acetate concentrated suspension 125 mg/mLAlso: Megace ESMegestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with normal renal function (CLcr >80 mL/min)	Drug	I
Megestrol acetate concentrated suspension 125 mg/mLAlso: Megace ESMegestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with mild renal impairment (CLcr 50 - 80 mL/min)	Drug	II
Megestrol acetate concentrated suspension 125 mg/mLAlso: Megace ESMegestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with moderate renal impairment (CLcr 30 - <50 mL/min)	Drug	III
Megestrol acetate concentrated suspension 125 mg/mLAlso: Megace ESMegestrol acetate concentrated suspension (125 mg/mL) administered orally for a total dose of 300 mg (2.4 mL x 125 mg/mL) in subjects with severe renal impairment (CLcr <30 mL/min and not on hemodialysis)	Drug	IV
Megestrol acetate concentrated suspension 125 mg/mLAlso: Megace ESMegestrol acetate concentrated suspension (125 mg/mL) administered orally as 2 single doses of 300 mg (2.4 mL x 125 mg/mL) each in subjects with end stage renal disease undergoing hemodialysis. Washout period of 21 days between each dose	Drug	V

Primary outcome

Pharmacokinetic blood samples
Time frame: predose and serially through 264 hours post dose
Urine collection
Time frame: Predose and serially through 264 hours post dose

Results and safety

The study was stopped early (reason given: Difficulty finding the required subject population). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.

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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.

Kenneth C Lasseter, MD principal investigator

SFBC International

Lynn D. Kramer, MD study director

Par Pharmaceutical, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Megestrol acetate concentrated suspension 125 mg/mL in people with Healthy, run by Par Pharmaceutical, Inc. 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 13 inclusion and 19 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: stopped early, as of the sponsor's last update on 17 Oct 2016. 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 was stopped early (reason given: Difficulty finding the required subject population). Results are not available in the source record.

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?

Pharmacokinetic blood samples (time frame: predose and serially through 264 hours post dose). The study lists 2 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 NCT00637403.

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 17 Oct 2016.