PrimarySafety and tolerability of MVT-602 following single dose subcutaneous administration in healthy premenopausal womenSecondaryPharmacokinetics (PK) and pharmacodynamics (PD) of MVT-602 following single dose subcutaneous administration
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety parameters including: adverse events , change in vital signs, laboratory
tests, and electrocardiograms (ECG).
Secondary outcome
Plasma pharmacokinetic parameters: AUC(0 *), AUC(0-t), AUC(0-24), Cmax, tmax,
t*, CL/F, and Vz/F.
Change in luteinizing hormone (LH), follicle stimulating hormone (FSH),
estradiol (E2), progesterone (P).
Background summary
MVT-602 is a drug developed for the treatment of infertility in women.
Infertility affects 9% of all couples worldwide. One of the causes of
infertility in women may be due to a disturbed hormone retention. Sexual
hormones are made in the ovaries and are necessary for ripening, so that they
can subsequently be fertilized. Certain so-called regulatory hormones, which
are made and secreted by cells in the brain, control the production of the sex
hormones in the ovaries.
Current infertility treatments due to hormonal disorders have a disadvantage
that the ovaries can be overstimulated which can result in side effects such as
abdominal pain and nausea. The chance of getting pregnant is often not greater
than 50%.
The study drug MVT-602 stimulates the cells in the brain to deliver more
regulatory hormones to the body. Because MVT-602 does not cause increased
hormone production, it is expected that treatment with this study drug will not
cause overstimulation of the ovaries.
Study objective
Primary
Safety and tolerability of MVT-602 following single dose subcutaneous
administration in healthy premenopausal women
Secondary
Pharmacokinetics (PK) and pharmacodynamics (PD) of MVT-602 following single
dose subcutaneous administration
Study design
Randomized, single blind, placebo-controlled, parallel-group dose-ranging study
Intervention
A single dose of study treatment will be administered as a subcutaneous
injection
Study burden and risks
The dosage levels of the study drug are based on a previous clinical trial
conducted by the sponsor. The risk to health at the chosen dose is limited, but
the patients may experience any of the side effects in the ICF or symptoms that
have not been reported before.
Volunteers health is closely monitored during the study to minimize these
risks. If the volunteers experience side effects, the investigator will treat
them where necessary. If new information is available on the safety of the
study medication, the volunteers are informed as soon as possible.
The blood collection procedure is not dangerous.
Viaduktstrasse 8
Basel 4051
CH
Viaduktstrasse 8
Basel 4051
CH
Listed location countries
Age
Inclusion criteria
1. Premenopausal female between 18 and and 35 years of age inclusive, at the time of signing the informed consent.
2. Healthy as determined by the investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
3. A history of regular menstrual periods (3 or more consecutive days of bleeding requiring protection) with cycle lengths of 21 to 35 days for the 3 months prior to study enrollment.
4. Subject agrees to use one of the nonhormonal contraception methods listed in Section 5.6.1 for the screening period, treatment period, and until the final study visit 30 to 45 days after the dose of study treatment
5. Body Mass Index within the range 18.0-30.0 kg/m2 (inclusive).
6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Exclusion criteria
1. The subject has a medical history of infertility or ovarian hyperstimulation syndrome, or received treatment for infertility within 3 months immediately prior to screening
2. A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at Screening.
3. A positive test for human immunodeficiency virus (HIV) antibody at Screening.
4. The subject has a positive pre-study drug/alcohol screen. There will be screened for Amphetamines, barbiturates, cocaine and opiate
5. Screening aspartate aminotransferase (AST), alanine aminotransferase (ALT), or direct bilirubin value greater than 1.25X the upper limit of normal (ULN) or serum creatinine greater than 1.5X ULN. A single repeat is allowed for eligibility determination.
6. Serum TSH/Prolactin outside normal range or history of thyroid disease or hyperprolactinemia.
7. Current use (within 1 month of study Day 1) of tobacco/nicotine/vaping/e-cig products.
8. History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >7 drinks. One drink is equivalent to 12 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
9. The subject has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
10. Pregnant females as determined by positive serum or urine human chorionic gonadotropin test at Screening or prior to dosing.
11. Lactating females.
12. Donation of blood or blood products within the 60-day period before Day 1 and intention to donate blood or blood products within the 60-day period after Day 4 of study.
13. History of sensitivity to any of the study treatment, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or sponsor Medical Monitor, contraindicates their participation.
14. Subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
15. The subject has uncontrolled or clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, neoplastic or endocrine disease or other abnormality that may impact the ability of the subject to participate or potentially confound the study results.
16. Subjects with a pre-existing condition interfering with normal hepatic and/or renal function, that could interfere with the metabolism and/or excretion of the study treatment.
17. Use of:
* Prescription or non-prescription drugs, including herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior dosing of study treatment;
* Hormonal preparations or analogues, including oral contraceptive pills and hormonal IUDs, within 1 month prior dosing of study treatment;
* GnRH/lutenizing hormone releasing hormone (LHRH) agonists within two-times the dose interval prior to dosing of study treatment (e.g., a 3-month depot injection of leuprolide acetate would require a 6-month washout);
unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise study objectives or subject safety.
18. The subject*s systolic blood pressure is outside the range of 90-150 mmHg, or diastolic blood pressure is outside the range of 40-95 mmHg or heart rate is outside the range of 40-100 bpm (a single repeat is allowed for eligibility determination).
19. Exclusion criteria for screening ECG (a single repeat is allowed for eligibility determination if ECG is considered by the investigator to be technically flawed):
Heart rate <40 and >100 bpm
PR Interval <120 and >220 msec
QRS duration <70 and >120 msec
QTcF >450 msec;* Evidence of previous myocardial infarction (does not include ST segment changes associated with repolarization).
* Any clinically significant conduction abnormality [including but not specific to left or right complete bundle branch block, AV block (2nd degree or higher), Wolff-Parkinson-White (WPW) syndrome (unless curative ablation treatment done)].
* Evidence of sinus pauses > 3 seconds.
* Evidence of any significant arrhythmia which, in the opinion of the investigator, will interfere with the safety for the individual subject.
* Evidence of non-sustained or sustained ventricular tachycardia (*3 consecutive ventricular ectopic beats).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2017-003812-38-NL |
CCMO | NL63413.056.17 |