Pharmacokinetics of the CYP3A substrate Midazolam after steady-state dosing of IMU-935.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

1. Sex : male or female of nonchildbearing potential
2. Age : 18 to 65 years, inclusive, at screening
3. Body mass index : 18.0 to 32.0 kg/m2, inclusive, at screening
4. Weight : >=55 kg at screening
5. Status : healthy subjects per discretion of the Investigator
6. Female subjects must be of nonchildbearing potential (either surgically
sterilized or
physiologically incapable of becoming pregnant, or at least 1 year
postmenopausal
[amenorrhea duration of 12 consecutive months]) and have a negative serum
pregnancy test at screening and a negative urine pregnancy test at each
admission
to the clinical research center.
7. Male subjects, if not surgically sterilized, must agree to use adequate
contraception and not donate sperm from first admission to the clinical
research center until 90 days after the follow-up visit. Adequate contraception
for the male subject (and his female partner, if she is of
childbearing potential) is defined as having his female partner using hormonal
contraceptives or an intrauterine device combined with the use of a condom by
the male subject for any sexual activity
Total abstinence, in accordance with the lifestyle of the subject, is also
acceptable.
8. All prescribed medication must have been stopped at least 30 days prior to
first
admission to the clinical research center.
9. All over-the-counter medication, vitamin preparations and other food
supplements,
or herbal medications (eg, St. John*s wort) must have been stopped at least
14 days prior to first admission to the clinical research center. An exception
is made
for paracetamol, which is allowed up to admission to the clinical research
center.
10. Ability and willingness to abstain from alcohol from 48 hours (2 days)
prior to
screening, each admission to the clinical research center, and follow-up, and
during
the stays in the clinical research center.

Further criteria apply, see protocol.

Exclusion Criteria

1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of relevant drug and/or food allergies.
4. Patients with a history of acute angle-closure glaucoma or untreated
open-angle
glaucoma.
5. Using tobacco products within 60 days prior to the first drug administration.
6. History of alcohol abuse or drug addiction (including soft drugs like
cannabis
products).
7. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines
[including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic
antidepressants, cotinine, and alcohol) at screening or at one of the
admissions to
the clinical research center.
8. Average intake of more than 24 units of alcohol per week (1 unit of alcohol
equals
approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
9. Estimated glomerular filtration rate calculated by the Chronic Kidney Disease
Epidemiology Collaboration creatinine equation <60 mL/min/1.73m2.
10. Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus
(HCV)
antibodies, or HIV 1 and 2 antibodies.

Further criteria apply, see protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To assess the effect of multiple doses of IMU-935 on the PK of midazolam and<br /><br>1*-hydroxymidazolam<br /><br>after a single oral dose of midazolam when co-administered in healthy male and<br /><br>female subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the PK of IMU-935.<br /><br><br /><br>- To assess safety and tolerability of a single oral dose of midazolam alone<br /><br>and in combination with steady-state IMU-935.<br /><br><br /><br>- To assess safety and tolerability of multiple oral doses of IMU-935.</p><br>