A safety, tolerability, and pharmacokinetic study of single- and multipleascending doses of LY3473329 in healthy subjects.

Completed

Conditions: Hyperlipidemie
fat metabolism disorder
Hyperlipidemia

Registration Number: NL-OMON54964

Lead Sponsor: Eli Lilly

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 113

Inclusion Criteria

1. Healthy male subjects, as determined through medical history and physical
examination,
must agree to use a reliable method of birth control
2. Healthy female subjects of child-bearing potential who have a fertile male
sexual partner
must be willing and able to practice effective contraception from admission to
105 days
beyond the last dose of study drug. Sexually active subjects must use a
combination of 2
of the following methods of contraception, including at least 1 so-called
*barrier* method
3. Aged 18 to <55 years, exclusive, at screening.

Exclusion Criteria

1. Are currently enrolled in, or discontinued within the past 30 days from, a
clinical trial
involving an investigational drug that has not received regulatory approval for
any indication,
except for any trial involving antisense Lp(a), for which 6 months must have
passed from the
subject*s last study drug dose.
2. Have previously completed or withdrawn from this study or any other study
investigating
LY3473329.
3. Are pregnant or breast feeding.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary (Part A - SAD) To evaluate safety and tolerability of LY3473329 in<br /><br>healthy subjects following a single oral dose<br /><br>Primary (Part B - MAD) To evaluate safety and tolerability of LY3473329 in<br /><br>otherwise healthy subjects with elevated Lp(a) (>=75 nmol/L or 30 mg/dL)<br /><br>following multiple once-daily oral doses</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary (Part A - SAD) To evaluate the pharmacokinetics of LY3473329 in<br /><br>healthy subjects following a single oral dose<br /><br>Secondary (Part B - MAD) To evaluate the pharmacokinetics of LY3473329 in<br /><br>otherwise healthy subjects with elevated Lp(a) (>=75 nmol/L or 30 mg/dL)<br /><br>following multiple once-daily oral doses</p><br>