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Lybridos Food effect study Voedsel effect onderzoek naar Lybridos


- candidate number20761
- NTR NumberNTR4862
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-okt-2014
- Secondary IDsNL50357.056.14 CCMO
- Public TitleLybridos Food effect study Voedsel effect onderzoek naar Lybridos
- Scientific TitleA randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of buspirone after a single oral administration of Lybridos in healthy female subjects
- ACRONYM
- hypothesisPrimary objective
1. To determine the effect of food on the pharmacokinetics of buspirone administered as the Lybridos formulation
Secondary objective
1. To evaluate the safety and tolerability of a single dose of Lybridos under fasted and fed conditions
- Healt Condition(s) or Problem(s) studiedSexual function
- Inclusion criteria1. Provision of informed consent
2. Females between 18 and 55 years of age (both inclusive)
3. Healthy based on medical history, physical examination (including vital signs), electrocardiogram, laboratory values
4. Body mass index (BMI) ≥18 kg/m2 and ≤ 30 kg/m2
5. Venous access sufficient to allow blood sampling as per protocol
- Exclusion criteriaCardiovascular conditions
1. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
2. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure< 50 mmHg

Gynaecological and obstetric conditions
3. Use of oral contraceptives containing anti-androgens (e.g. crypteron acetate) or anti (androgenic) progestogens (drosperidone, dienogest, chlormadinone acetate and norgestrel)
4. Use of any hormone replacement therapy (HRT) containing more than 50 g/day of estrogen
5. Pregnancy (note: an urine pregnancy test will be performed in all women prior to the administration of study medication)
6. Lactating or delivery in the previous 6 months
7. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night contraceptive sweating) in combination with elevated FSH levels (>40 IU/L) for women age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms)

General
8. Use of any drugs from two weeks prior to admission to the research unit until the follow-up visit, except for allowed oral contraceptives and pain relief (e.g. paracetamol up to 1.5 g per day)
9. Known or suspected hypersensitivity to any of the components of the formulation
10. Liver function tests (i.e., alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin) significantly above the upper limit of normal (ULN) at repeated measures
11. Any clinically significant history or any other disease or disorder- gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric, or metabolic as judged by the medical investigator
12. Smoking
13. Unwilling or unable to refrain from consuming grapefruit juice, star fruit and St. Johns Wort 24 hours before and after intake of medication
14. Current regular use of any illicit drugs or history of excessive drinking within 3 months prior to admission to the research unit and/or unwilling or unable to refrain from products containing alcohol from 24 hours before admission and during the stay in the research unit
15. Donation of blood within 3 months prior to admission to the research unit
16. Positive serology test for hepatitis B serum antigen (HBsAg), anti-hepatitis A virus (HAV) (IgM), anti-hepatitis C virus (HCV) or anti human immunodeficiency virus (HIV) 1+2
17. Subjects who, in the opinion of the investigator, are not likely to complete the trial for any reason
18. Participation in any clinical study within 1 month prior to the expected date of enrolment into the study.
19. Employees of the sponsor or CRO involved in the study
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 26-jan-2015
- planned closingdate13-mrt-2015
- Target number of participants18
- InterventionsLybridos 2 gifts
- Primary outcome90% CI ratio for both AUC0-inf and Cmax
- Secondary outcomePharmacokinetic
Difference in Tmax and tlag and
-Area under the concentration time curve (AUC)
-Peak exposure (Cmax)
-Time to peak exposure (Tmax)
-Lag time (tlag)
-Terminal elimination half-life (t)

Safety
A. Nature, frequency and severity of AEs
B. Vital signs and 12-lead ECG
C. Safety laboratory tests (urinalysis, haematology, biochemistry)
- TimepointsA total of 18 subjects receive the investigational drug. During the 2 experimental days (where bloodsampling for PK analysis will take place), subjects receive Lybridos under Fed and Fasted conditions in random order. Subjects visit the site total of 8 times: 1 screening visit, 1 experimental day for two times in a crossover (consisting of an admission,day 1 and day 2) and 1 final follow up visit.
- Trial web sitewww.emotionalbrain.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Gerritsen
- CONTACT for SCIENTIFIC QUERIES J. Bloemers
- Sponsor/Initiator Emotional Brain BV
- Funding
(Source(s) of Monetary or Material Support)
Emotional Brain BV
- Publications
- Brief summaryA total of 18 subjects receive the investigational drug. During the 2 experimental days (where bloodsampling for PK analysis will take place), subjects receive Lybridos under Fed and Fasted conditions in random order. Subjects visit the site total of 8 times: 1 screening visit, 1 experimental day for two times in a crossover (consisting of an admission,day 1 and day 2) and 1 final follow up visit.
- Main changes (audit trail)
- RECORD23-okt-2014 - 22-nov-2014


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