Primary : To evaluate the safety and tolerability of single oral doses of LY3045697 administered to healthy subjects Secondary : To investigate the pharmacokinetics of single oral doses of LY3045697 administered to healthy subjects Exploratory : To…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tollerability of LY3045697
Secondary outcome
Pharmacokinetics of LY3045697
Background summary
LY3045697 is a new investigational compound that may eventually be used for the
treatment of chronic kidney disease (CKD). LY3045697 is not registered as a
drug. This is the first time that this compound is being given to humans. This
study is necessary for the further development of LY3045697.
Study objective
Primary : To evaluate the safety and tolerability of single oral doses of
LY3045697 administered to healthy subjects
Secondary : To investigate the pharmacokinetics of single oral doses of
LY3045697 administered to healthy subjects
Exploratory : To explore the effect of LY3045697 on sodium and potassium renal
handling
: To explore the pharmacodynamic effects on aldosterone, cortisol and
their steroidogenic precursors (e.g. 11-deoxycortisol, 11-deoxycorticosterone,
corticosterone) after single dose administration of LY3045697 in healthy
subjects
Study design
This is a randomized, double blind, placebo-controlled, dose escalating,
incomplete cross-over design study in healthy males and females of non-child
bearing potential in 2 groups of 9 subjects (6 subjects on active and 3 on
placebo) each. Groups 1 and 2 will be dosed in an alternating fashion during 3
separate admission periods. The 3rd group will be dosed in two consecutive
periods. There will be a wash-out period of at least 5 days between dose levels
for an individual subject. Dosing will be in the fed state. Subjects will
receive placebo in one period only.
Intervention
Single oral dose of LY3045697 or placebo
Study burden and risks
As LY3045697 will be administered to humans for the first time in this study,
no adverse effects have been reported to date. Animal studies showed that
LY3045697 was well tolerated in rats for 28 days at very high doses (1000
mg/kg). In monkeys this was the case for doses of 30 mg/kg. In both species
there was a slight increase in weight and volume of the liver and adrenal
glands.
LY3045697 may reduce blood aldosterone levels. LY3045697 may cause increased
potassium levels which could cause abnormal heart rhythm. LY3045697 may also
cause blood pressure to drop. LY3045697 may also reduce blood cortisol levels.
Lack of cortisol may result in abdomen pain, nausea and vomiting, muscles
aches, loss of appetite and weight, lack of energy and a low blood pressure.
LY3045697 may reduce the amount of sodium in your blood. Subjects may also
experience increased urination.
Lilly Corporate Center n/a
Indianapolis IN 46285
US
Lilly Corporate Center n/a
Indianapolis IN 46285
US
Listed location countries
Age
Inclusion criteria
-Healthy males or females (postmenopausal or surgically sterile)
-Postmenopausal female subjects must be between the ages of 45 and 65 years, inclusive
-Male subjects and surgically sterile females must be between the ages of 18 and 65 years, inclusive
-BMI between 18.0 and 32.5 kg/m2 , inclusive
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004968-22-NL |
| CCMO | NL42881.056.12 |