PharmacokineticsPhase 1NCT00638079
Evaluating the Effect of Food on Absorption of Megace ES
A Phase 1 study testing Megestrol acetate oral suspension 625 mg/5 mL in people with Pharmacokinetics and Bioavailability, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in Canada.
Trial summary
To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Bioavailability, Absorption
- What is being tested?
- Megestrol acetate oral suspension 625 mg/5 mL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jun 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32
- Healthy
Who cannot join
- History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors), or excretion of study drug
- History of or any current medical conditions that could affect subject safety
- History of frequent nausea or emesis, regardless of etiology
- Participation in a clinical drug study during the 30 days preceding the initial dose
- Significant illness during the 4 weeks preceding study entry
- Use of any medication, including vitamins/herbal/mineral supplements, during the 7 days preceding the initial dose
Show all 12Show fewer
- Refusal or inability to abstain from food 10 hours proceeding and 4 hours following study drug administration, to consume the FDA high fat meal as directed, and to abstain from caffeine- or xanthine-containing beverages entirely during each confinement
- Any history of or current drug or alcohol abuse
- Prior alcohol intake exceeding the equivalent of 14 units/week (12 oz beer = 4 oz wine = 1.5 oz shot = 1 unit) on average, or consumption of any alcoholic beverages within 48 hours of study drug administration
- History of smoking>25 cigarettes/day within 45 days of study drug administration
- Blood or blood products donated within 30 days prior to study drug administration, or anytime during the study, except as required by this protocol
- Positive results of urine drug screen, blood alcohol by a Breathalyzer test, hepatitis B surface antigen, hepatitis B surface antibody (unless immunized), or anti-HCV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in Healthy Subjects
To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.
- Conditions
- Pharmacokinetics, Bioavailability, Absorption
- Being tested
- Megestrol acetate oral suspension 625 mg/5 mL
- Keywords
- Pharmacokinetics, Food Effect, Bioavailability, Megace ES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Megestrol acetate oral suspension 625 mg/5 mLDrug
Also called Megace ES
Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal
Megestrol acetate oral suspension 625 mg/5 mLDrug
Also called Megace ES
Megestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal Receives: Drug: Megestrol acetate oral suspension 625 mg/5 mL |
| B | Active comparator | Megestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast Receives: Drug: Megestrol acetate oral suspension 625 mg/5 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and extent of absorption
Measured: 120 hours (5 days)
Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.
Measured: signing of informed consent to 30 days after last study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startJun 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 PharmacokineticsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SFBC Anapharm
- Responsible party
- Sponsor
- Investigators
- Benoit Deschamps, MD, Principal investigator, SFBC AnapharmTodd Kirby, PhD, Study director, Endo USA Inc., a Keenova Therapeutics Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638079
- Sponsor's protocol ID
- PAR 100.1.C.003
- Status last verified
- Aug 2015
- First submitted
- 11 Mar 2008
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10.
PubMed 19774117
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Open-label, 2-way Crossover Bioavailability Study, Evaluating the Effect of Food on Megace ES (Megestrol Acetate 625 mg/5 mL Oral Suspension) Following a 625 mg Dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00638079
- Acronym / sponsor ID
- PAR 100.1.C.003
- Conditions
- Pharmacokinetics, Bioavailability, Absorption
- Keywords
- Pharmacokinetics, Food Effect, Bioavailability, Megace ES
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics CompanyIndustry (pharma, biotech, devices)
- Collaborators
- SFBC Anapharm
- Study start
- Jun 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 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.
To evaluate the effect of food on the rate and extent of absorption of megestrol acetate 625 mg/5 mL , and determine the safety and tolerability of megestrol acetate 625 mg/5 mL in healthy individuals.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Megestrol acetate oral suspension 625 mg/5 mLMegestrol acetate 625 mg/5 mL oral suspension (Megace ES) with a high fat meal |
| B | Active comparator | Drug: Megestrol acetate oral suspension 625 mg/5 mLMegestrol acetate 625 mg/5 mL oral suspension (Megace ES) following an overnight fast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body weight ranging from 60-100 kg (132-220 lbs) and body mass index ≥18 and ≤32
- Healthy
Key exclusion criteria (12 listed)
- History of or any current medical conditions that could interfere with drug consumption, absorption, distribution, metabolism (eg. CYP450 inducers or inhibitors), or excretion of study drug
- History of or any current medical conditions that could affect subject safety
- History of frequent nausea or emesis, regardless of etiology
- Participation in a clinical drug study during the 30 days preceding the initial dose
- Significant illness during the 4 weeks preceding study entry
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 oral suspension 625 mg/5 mLAlso: Megace ESMegestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered with a high fat meal | Drug | A |
| Megestrol acetate oral suspension 625 mg/5 mLAlso: Megace ESMegestrol acetate oral suspension 625 mg/5 mL. Single dose (5 mL) administered following an overnight fast | Drug | B |
Primary outcome
Rate and extent of absorption
Time frame: 120 hours (5 days)
Safety assessed using adverse events (AEs), clinical laboratory results, vital signs, physical examinations, and ECGs.
Time frame: signing of informed consent to 30 days after last study visit
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 19 Apr 2016.
- Results publication: PubMed 19774117Deschamps B, Musaji N, Gillespie JA. Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension. Int J Nanomedicine. 2009;4:185-92. doi: 10.2147/ijn.s6308. Epub 2009 Sep 10.
- International Journal of NanomedicineLink provided by the sponsor.
Related trials for Pharmacokinetics
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
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.
Benoit Deschamps, MD principal investigator
SFBC Anapharm
Todd Kirby, PhD study director
Endo USA Inc., a Keenova Therapeutics Company
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 oral suspension 625 mg/5 mL in people with Pharmacokinetics and Bioavailability, run by Endo USA Inc., a Keenova Therapeutics Company at 1 site in Canada.
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 2 inclusion and 12 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 19 Apr 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 Canada. 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?
Rate and extent of absorption (time frame: 120 hours (5 days)). 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 NCT00638079, 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 19 Apr 2016.