A double-blind, randomized, placebo-controlled, cross-over, single center, pharmacodynamic trial to collect data for quantitative modeling of HPA axis modulation with desmopressin and CRH in healthy volunteers
- Conditions
- depression and stress axis10027946
- Registration Number
- NL-OMON31986
- Lead Sponsor
- Organon Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
1. Age of 18-45 years (extremes included) at Screening;
2. A body mass index (BMI) of 18-28 kg/m2 (extremes included).
3. (History of) good physical and mental health as determined by history taking,
physical and laboratory examinations, ECG and vital signs recordings;
4. Able and willing to sign the Informed Consent Form prior to screening
evaluations;
5. Able to refrain from all use of (methyl)xanthines (e.g. coffee, tea, cola,
chocolate) during the stay at the CHDR clinic;
6. Able to refrain from strenuous physical exercise from 48-hours prior to each
dosing until dismissal from the CHDR clinic;
7. Smoke less than 5 cigarettes or equivalent per day (amount to be registered)
and capable of not smoking during the study days.
8. Females of child bearing potential should use either hormonal contraception in
combination with a barrier method (condom, or diaphragm with spermicide), an
IUD, or abstinence for the duration of the trial. If the partner is vasectomized an
additional barrier method must be used. Males should use any measure to
prohibit a pregnancy (vasectomy, a barrier method, or abstinence).
1. History of drug sensitivity;
2. Use of any drug or substance within one week prior to the first dosing, except for
paracetamol and some topical medication (as to judgment of the investigator);
3. Clinically relevant history, family history or presence of any medical disorder,
potentially interfering with this trial, - in particular hypercoagulability demonstrated
by either known coagulation factor deficiencies (e.g. Factor V Leiden mutation,
APC resistance) or previous pulmonary embolism/deep venous thrombosis,
arterial thromboembolism, other (arterial) cardiovascular diseases, diabetes
insipidus, renal diseases, polydypsia -, or its risk factors;
4. ADAMTS13 deficiency;
5. Personal history of, or parents, children, brothers or sisters with, a psychiatric
disease;
6. Subjects with disturbed day/night rhythm due to e.g. working in night-shifts or
traveling over time zones within 3 weeks prior to the first dose;
7. History of or current abuse of drugs or alcohol (mean intake of more than 4 units
per day) or solvents.
8. Positive drug (at screening and/or admission) or alcohol screen (at screening).
9. Positive test result on hepatitis B surface antigen or hepatitis C antibodies;
10. Positive test result on HIV 1/2 serology;
11. Participation in an investigational drug study within 90 days prior to the first dose;
12. Donation of blood within 90 days prior to the first dose;
13. Pregnancy as confirmed by positive pregnancy test at screening and admission
or lactation.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics:<br /><br>1. dDAVP<br /><br>2. human CRH<br /><br><br /><br>Pharmacodynamics:<br /><br>1. ACTH<br /><br>2. total and free cortisol</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. to evaluate the safety of dDAVP and hCRH injections<br /><br>2. to bank DNA, extracted from blood samples, for future association studies of<br /><br>genotype with the pharmacokinetic, pharmacodynamic and safety characteristics<br /><br>obtained in this trial<br /><br>3. to obtain results of questionnaires on mood, anxiety state and personality<br /><br>structure for future analysis of these psychological characteristics in<br /><br>relation to HPA axis sensitivity.</p><br>