Status:
COMPLETED
Thorough QT/QTc Study of Multiple Oral Doses of NOMAC-E2 (Org 10486 0 + Org 2317) in Healthy Women (Study 292011)(P05802)
Lead Sponsor:
Organon and Co
Conditions:
Contraception
Eligibility:
FEMALE
18-50 years
Phase:
PHASE1
Brief Summary
The trial is a single-center randomized, double-blind, double-dummy, placebo and positive controlled, parallel group clinical trial. This trial investigated whether NOMAC-E2 (Org 10486 -0 + Org 2317)...
Eligibility Criteria
Inclusion
- Female (aged 18-50 years) with a body mass index (BMI) of 17 \<= BMI \<= 29 kg/m\^2 at screening;
- Able and willing to use non-hormonal contraceptives during the trial from at least 2 weeks prior to Day 1 up to and including follow-up;
- Able and willing to sign the Informed Consent Form prior to screening evaluations;
- Subject is in a good age-appropriate healthy condition as established by medical history, physical examination, cardiac monitoring, electrocardiogram, results of biochemistry, hematology and urinalysis testing within 4 weeks prior to treatment as judged by the investigator;
- Normal 12-lead automatic ECG at screening and admission;
- Subject has a normal blood pressure at screening and admission;
- Subject smokes less than 5 cigarettes or equivalent per day and is capable of not smoking from 48 hours prior drug administration on Day -1 and Day 14 until the last ECG has been taken on respectively Day 1 and Day 15;
- Able to refrain from all use of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) from 48 hours prior to drug administration on Day -1 and Day 14 until the last ECG has been taken on respectively Day 1 and Day 15;
- Able to refrain from alcohol containing beverages from 24 hours prior to drug administration on Day -1 and Day 14 until the last ECG has been taken on respectively Day 1 and Day 15;
- Able to refrain from all use of grapefruit containing products from 14 days prior to first NOMAC-E2 dosing until the last ECG has been taken;
- Easy venous accessibility.
Exclusion
- History of sensitivity/idiosyncrasy to the applied drugs or chemically related compounds or excipients which may be employed in the study or to any other unknown drug used in the past
- Use of any drug or substance within one week and hormonal contraception within 2 weeks prior to the first treatment day, except for paracetamol or topical medication without systemic exposure
- Present use or use during 2 months prior to the start of treatment of any drugs interfering with the trial medication;
- Clinically relevant history or presence of any medical disorder, potentially interfering with this trial (according to the investigator)
- Known or suspected pregnancy
- History of/or current abuse of drugs or alcohol or solvents, or positive drug or alcohol screen at screening and admission, as judged by the (sub-)investigator
- Positive test result on hepatitis B surface antigen, hepatitis C antibody, or HIV 1/2 serology
- Participation in an investigational drug trial within 90 days prior to treatment
- Donation of blood within 90 days prior to treatment
- Contraindications for contraceptive steroids
- Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication.
- Present use or use within one month prior to treatment or within 10 half-lives in case the half-life \> 3 days of any agent that is known to prolong the QT/QTc interval
- History of/or current risk factors for Torsade de Pointes (TdP) or life-threatening ventricular arrhythmia (e.g. heart failure, hypokaliemia, hypomagnesaemia, hypocalcaemia, family history of long or short QT syndrome, loss of consciousness)
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00779532
Start Date
May 1 2008
End Date
November 1 2008
Last Update
February 16 2022
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