ContraceptionPhase 1NCT02720224
Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol
A Phase 1 study testing Estetrol in people with Contraception and Menopause, run by Estetra at 1 site in United Kingdom.
Trial summary
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol). Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Contraception, Menopause
- What is being tested?
- Estetrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2016to Apr 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy females of non-child bearing potential, i.e. surgically sterilised or post menopausal subjects. Postmenopausal status will be defined by an absence of menses for a minimum of 12 months and confirmed by a FSH result ≥30 IU/ml
- Negative pregnancy test at screening and Day -1
- 30 to 65 years of age inclusive
- Body mass index between ≥18.0 and ≤30.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
- Must provide written informed consent
- Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)Must agree to use an adequate method of contraception
Who cannot join
- Participation in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption i.e. >14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)
- Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
Show all 31Show fewer
- Females who are pregnant or lactating
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed at screening
- Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
- Positive drugs of abuse test result
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History or presence of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
- Donation or loss of greater than 400 ml of blood within the previous 3 months
- Subjects who are taking, or have taken, any prescribed medications in the 28 days before IMP administration (exceptions may apply on a case by case basis provided they are considered not to interfere with the objectives of the study as agreed by the PI or delegate and sponsor's medical monitor), or over-the-counter drug or herbal remedies in the 14 days before IMP administration. If needed (i.e. an incidental and limited need) ibuprofen is acceptable as analgesic treatment, but must be documented in the (Case Report Form) CRF. Use of paracetamol is forbidden during the entire study
- Subjects who are not in euthyroid condition (thyroid-stimulating hormone [TSH] and free thyroxine [fT4] within the normal reference range)
- Any history of suspected malignancy with the exception of basal cell (excluded if within the prior 2 years) or squamous cell (excluded if within the prior one year) carcinoma of the skin
- History or presence of prolonged QT interval corrected by Bazett's formula or any other clinically significant ECG abnormalities as judged by the investigator based on 12-lead ECG readings at screening
- Subjects with abnormal supine blood pressure at screening: at least 2 readings of systolic blood pressure greater than 140 mmHg or lower than 90 mmHg, and/or diastolic blood pressure of more than 90 mmHg or lower than 50 mmHg after minimum intervals of 5 min
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The investigator should make this determination in consideration of the subject's medical history and/or clinical or laboratory evidence of any of the following:
- History or symptoms of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding,
- History of major gastrointestinal tract surgery (subjects who have had an appendectomy are acceptable for inclusion),
- History or presence of pancreatic injury or pancreatitis,
- History or presence of impaired hepatic function,
- History or presence of liver disease or liver injury as indicated by abnormal liver function tests such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), or total serum bilirubin. Any single parameter elevated ≥1.5 fold upper limit of normal should be re-checked once prior to enrolment/randomisation (subject who have had a cholecystectomy are acceptable for inclusion if all liver/gallbladder parameters are in the normal range),
- History or presence of impaired renal function if considered as clinically significant,
- Abnormal urinary constituents (e.g. albumin if considered as clinically significant).
- Suspected or current history of gynaecological or breast pathology, including any abnormal Pap smear within the 3 previous years (ASCUS , ASC-H , LGSIL or worse) or history of abnormal mammogram within the 2 previous years
- Failure to satisfy the investigator of fitness to participate for any other reason
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: An Open-Label, Single Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profiles and Metabolite Identification of [14C]-Estetrol in Healthy Female Volunteers
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
Read the detailed description
This will be an open-label, non-randomised, single dose study in healthy female volunteers of non-child bearing potential.
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. The study will be executed in a single group, 6 subjects will be enrolled and dosed with a single oral dose of carbon 14 labelled estetrol. Subjects will be admitted to the clinical unit on the morning prior to study drug administration (Day -1). Dosing will take place on the morning of Day 1 after an overnight fast (approximately 10 h).
Subjects will be resident in the clinic up to 240 h after dosing during which plasma, blood, urine and faeces samples will be collected. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if a mean of <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects on Day 11, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.
- Conditions
- Contraception, Menopause
- Being tested
- Estetrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstetrolDrug
Also called E4
15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C
| Study group | Role | What they receive |
|---|---|---|
| Estetrol | Experimental | A single oral dose of 15 mg carbon 14 labelled estetrol ([14C]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C Receives: Drug: Estetrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance of Total Radioactivity in Urine
Amount excreted in urine (Ae[urine])
Measured: From Day -1 prior study treatment intake to 312 hours post-dose
Mass Balance of Total Radioactivity in Faeces:
Amount excreted in faeces (Ae[faeces])
Measured: From Day -1 prior study treatment intake to 312 hours post-dose
Secondary outcomes (17)
Maximum Concentration (Cmax) of Total Radioactivity in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Time to Maximum Concentration (Tmax) of Total Radioactivity in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Area Under the Curve From 0 Time to Last Measurable Concentration [AUC(0-last)] of Total Radioactivity in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
The Elapsed Time (Tlag) of Total Radioactivity in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Cmax of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Tmax of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
AUC(0-last) of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
AUC(0-infinity) of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Tlag of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Half-life (t1/2) of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
The Mean Residence Time (MRT) of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Cmax of Total Radioactivity in Whole Blood
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
The Terminal Elimination Rate Constant (Lambda-z) of Estetrol in Plasma
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
AUC(0-last) of Total Radioactivity in Whole Blood
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Renal Clearance (CLr) for Estetrol
Measured: From Day-1 prior study treatment intake to 240 hours post-dose
Renal Clearance (CLr) for Total Radioactivity
Measured: From Day-1 prior study treatment intake to 240 hours post-dose
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
Measured: From maximum 28 days prior study treatment intake to 240 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Estetra
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Litza McKenzie, MBChB, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720224
- Sponsor's protocol ID
- MIT -Es0001-C105
- Other IDs
- 2014-000622-38, 2014
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2016
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profiles and Metabolite Identification of [14C]-Estetrol in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT02720224
- Acronym / sponsor ID
- MIT -Es0001-C105
- Conditions
- Contraception, Menopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- EstetraIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Posted 10 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol ([14C] estetrol).
Detailed description
This will be an open-label, non-randomised, single dose study in healthy female volunteers of non-child bearing potential.
Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. The study will be executed in a single group, 6 subjects will be enrolled and dosed with a single oral dose of carbon 14 labelled estetrol. Subjects will be admitted to the clinical unit on the morning prior to study drug administration (Day -1). Dosing will take place on the morning of Day 1 after an overnight fast (approximately 10 h).
Subjects will be resident in the clinic up to 240 h after dosing during which plasma, blood, urine and faeces samples will be collected. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of >90% or if a mean of <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects on Day 11, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estetrol | Experimental | Drug: EstetrolA single oral dose of 15 mg carbon 14 labelled estetrol ([14C]-estetrol), containing approximately 2.8 MBq (76 µCi) 14C |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy females of non-child bearing potential, i.e. surgically sterilised or post menopausal subjects. Postmenopausal status will be defined by an absence of menses for a minimum of 12 months and confirmed by a FSH result ≥30 IU/ml
- Negative pregnancy test at screening and Day -1
- 30 to 65 years of age inclusive
- Body mass index between ≥18.0 and ≤30.0 kg/m2
- Must be willing and able to communicate and participate in the whole study
Key exclusion criteria (31 listed)
- Participation in a clinical research study within the previous 3 months
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee
- Subjects who have previously been enrolled in this study
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption i.e. >14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)
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 |
|---|---|---|
| EstetrolAlso: E415 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C | Drug | Estetrol |
Primary outcome
Mass Balance of Total Radioactivity in Urine
Time frame: From Day -1 prior study treatment intake to 312 hours post-dose
Amount excreted in urine (Ae[urine])
Mass Balance of Total Radioactivity in Faeces:
Time frame: From Day -1 prior study treatment intake to 312 hours post-dose
Amount excreted in faeces (Ae[faeces])
17 secondary outcomes
Maximum Concentration (Cmax) of Total Radioactivity in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Time to Maximum Concentration (Tmax) of Total Radioactivity in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Area Under the Curve From 0 Time to Last Measurable Concentration [AUC(0-last)] of Total Radioactivity in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
The Elapsed Time (Tlag) of Total Radioactivity in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Cmax of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Tmax of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
AUC(0-last) of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
AUC(0-infinity) of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Tlag of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Half-life (t1/2) of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
The Mean Residence Time (MRT) of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Cmax of Total Radioactivity in Whole Blood
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
The Terminal Elimination Rate Constant (Lambda-z) of Estetrol in Plasma
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
AUC(0-last) of Total Radioactivity in Whole Blood
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours post-dose
Renal Clearance (CLr) for Estetrol
Time frame: From Day-1 prior study treatment intake to 240 hours post-dose
Renal Clearance (CLr) for Total Radioactivity
Time frame: From Day-1 prior study treatment intake to 240 hours post-dose
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
Time frame: From maximum 28 days prior study treatment intake to 240 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Litza McKenzie, MBChB principal investigator
Quotient Clinical
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 Estetrol in people with Contraception and Menopause, run by Estetra at 1 site in United Kingdom.
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 7 inclusion and 31 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 15 Feb 2019. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mass Balance of Total Radioactivity in Urine (time frame: From Day -1 prior study treatment intake to 312 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?
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 15 Feb 2019.