P06356

Phase 1

• Conditions: This study is going to be conducted in heathy volunteers.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2010-020832-20-NL
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation - for Global trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-29
• Study Completion: 2011-05-23
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

2. Subjects of either sex and of any race between the ages of 18 and 65 years, inclusive, having a Body Mass Index (BMI) between 19 to 35, inclusive. BMI = weight (kg)/height (m2).
3. Subjects’ clinical laboratory tests (CBC, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator. Subject’s liver function test results (ie, AST, ALT, and GGT) must not be elevated above the normal limits at Screening and on Day -1.
4. Subjects must be free of any clinically significant disease, especially onychomycosis that would interfere with the study evaluations.
5. Subjects must have suitable veins for cannulation and no previous thrombophlebitis.
6. Screening ECG conduction intervals must be within gender specific normal range (QTc males ?430 msec and females ?450 msec).
7. Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges:
a. systolic blood pressure, 90 to 140 mm Hg
b. diastolic blood pressure, 45 to 90 mm Hg
c. pulse rate, 40 to 100 bpm
8. Female subjects must be:
a. postmenopausal (defined as 12 months with no menses and with a FSH level of >35 u/L), and/or
b. surgically sterilized (eg, documented hysterectomy or tubal ligation)
Female subjects who are premenopausal and unsterilized must:
a. have used a medically accepted method of contraception for 2 months (or abstained from sexual intercourse) prior to the screening period. An acceptable method of contraception includes one of the following:
i. stable oral/transdermal/injectable hormonal contraceptive regimen without breakthrough uterine bleeding for 2 months prior to Screening visit and a condom with spermicide.
ii. intrauterine device (inserted at least 2 months prior to Screening visit) used with spermicide.
iii. condom (male or female) with spermicide,
iv. diaphragm or cervical cap with spermicide and condom,
Note: Vasectomy of the partner is not considered sufficient contraception and one of the 4 bulleted methods listed above must be used in conjunction with a condom (male or female) with spermicide, or diaphragm (or cervical cap).
b. agree to use one of the accepted methods of contraception (listed above) during the trial (including the screening period prior to receiving trial medication), and for 2 months after stopping the trial medication. Females who are not currently sexually active must also consent to use one of these accepted methods of contraception should they become sexually active while participating in the study.
9. Men must agree to use a medically accepted method of contraception (see Section 7.3.1.7 above), or abstain from sexual intercourse, during the trial and for 1 month after stopping the medication.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Female subjects who are pregnant, intend to become pregnant (within 3 months of ending the study), or are lactating.
2. Anyone with a fungal infection that has occurred within 3 months of study start.
3. Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study (e.g., potassium, magnesium and calcium levels > 10% of their normal ranges).
4. Subjects who have been diagnosed with or suspect to have cardiomyopathy, or have a history of any types of heart diseases.
5. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following and be discussed with the sponsor prior to enrollment into the trial:
a. history or presence of liver disease or liver injury;
b. history or presence of impaired renal function as indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or
c. history of urinary obstruction or difficulty in voiding.
6. Subject who has a history of any clinically significant infectious disease within 4 weeks prior to drug administration.
7. Subjects who are positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
8. Subjects who have a positive screen for drugs and alcohol with a high potential for abuse.
9. Subjects with a history of mental instability or who have been treated for mood disorders.
10. Subjects with a history of alcohol or drug abuse in the past 2 years.
11. Subjects who have donated blood in the past 60 days prior to frist dosing.
12. Subjects who have previously received this compound.
13. Subjects who are currently participating in another clinical study or have participated in a clinical study within 90 days prior to 1st dosing.
14. Subjects who are part of the study staff personnel or family members of the study staff personnel.
15. Subjects who have demonstrated clinically significant allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes).
16. Subjects who smoke more than 10 cigarettes or equivalent tobacco use per day or more than 21 units of alcohol per week or 2 units of caffeine per day..
17. Subjects who have received any treatment listed in Table 2 more recently than the indicated washout period prior to Baseline.
18. Subjects on any steroid treatment.
19. Subjects with an abnormal ACTH stimulation test on Day -2 (cortisol <550 nmol/L or <21 µg/dL (Part 2 only).
20. Subject with predose left ventricular EF < 50%.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified