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

A safety, tolerability, and pharmacokinetic study of single- and multipleascending doses of LY3473329 in healthy subjects. - SAD/MAD study of LY3473329 in Healthy Subjects.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54964

Enrollment

113

Registered

2020-07-14

Start date

2020-08-18

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemie fat metabolism disorder Hyperlipidemia

Interventions

Group A1 on Day 1 LY3473329 1 milligram (mg) or placebo, once Group A2 on Day 1 LY3473329 10 mg or placebo, once Group A3 on Day 1 LY3473329 30 mg or placebo once Group A4 on Day 1 LY3473329 100 mg or

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 Have previously completed or withdrawn from this study or any other study investigating LY3473329. 3.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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)