The purpose of this study is to investigate how safe the new compound LY3473329 is and how well it is tolerated when it is administered to healthy volunteers. It will also be investigated to determine how quickly and to what extent LY3473329 is…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hyperlipidemie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
In this study, LY3473329 is being researched. This study compound is not
registered in the Netherlands as a medication. This means that the study
compound is still in development and that it is not known whether the study
compound is safe and if it works. Lipoprotein (a) (Lp[a]) is a substance in the
blood that transports cholesterol, fats and proteins. The amount that the body
produces is inherited from one or both parents and is genetically determined.
Diet and exercise seem to have little or no effect on the Lp(a) level. Elevated
levels of Lp(a) are associated with increased risk of cardiovascular disease.
LY3473329 is a potential new compound that may decrease major adverse effects
in the heart in patients with elevated Lp(a) and cardiovascular disease caused
by atherosclerosis.
Study objective
The purpose of this study is to investigate how safe the new compound LY3473329
is and how well it is tolerated when it is administered to healthy volunteers.
It will also be investigated to determine how quickly and to what extent
LY3473329 is absorbed, distributed, metabolized and eliminated from the body
(this is called pharmacokinetics). In addition, the effect of LY3473329 on
certain naturally occurring substances present in your blood will be
investigated. LY3473329 has not been administered to humans before. It has been
previously tested in the laboratory and on animals. The animal studies showed
that LY3473329 decreased plasminogen, a protein that may have effects on blood
clotting. However, the animals showed no changes to the clotting of their blood.
LY3473329 will be given as oral capsules and will be tested at different dose
levels. The effects of LY3473329 will be compared to the effects of a placebo.
A placebo is a capsule that does not contain any active compound. Whether the
volunteer will receive LY3473329 or placebo will be determined by chance. This
study will be performed in up to 113 healthy volunteers. The study will exist
of 2 parts, Part A and Part B. The study part in which the volunteer will
participate will consist of a maximum of 7 groups of 8 volunteers each. They
can participate in one of these groups based on their preference for a specific
time period or group.
Study design
The actual study will consist of 1 period during which the volunteers will stay
in the research center for 5 days (4 nights). Also, there will be 7 days during
which they will visit the research center for a short visit. These short visits
will take place on Days 8, 15, 22, 43, 64, 85 and 106 (follow-up).
Day 1 is the day of administration of the study compound. The volunteers are
expected at the research center at 14:00 h in the afternoon of Day -1, 1 day
prior to the day of administration of the study compound. The entry time can be
changed.
They will leave the research center on Day 4 of the study. For the short visits
on Days 8, 15, 22, 43, 64, 85 and 106 they are expected at the research center
between 12:30 h and 14:30 h in the afternoon. They will be tested for the
presence of coronavirus upon entry into the research center.
Intervention
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 placebo, once
Group A5 on Day 1 LY3473329 200 mg or placebo, once
Group A6 on Day 1 LY3473329 400 mg or placebo once
Group A7 on Day 1 LY3473329 800 mg or placebo once
Group B1 on days 1-14 LY3473329 1 milligram (mg) or placebo, once daily
Group B2 on days 1-14 LY3473329 5 mg or placebo once daily
Group B3 on days 1-14 LY3473329 20 mg or placebo once daily
Group B4 on days 1-14 LY3473329 50 mg or placebo once daily
Group B5 on days 1-14 LY3473329 100 mg or placebo once daily
Study burden and risks
Drawing blood and/or insertion of the indwelling cannula may be painful or
cause some bruising.
In total, there will be taken about 240 mL of blood. This amount does not cause
any problems in adults. To make a heart tracing, electrodes (small, plastic
patches) will be pasted at specific locations on the arms, chest and legs.
Prolonged use of these electrodes can cause skin irritation (rash and itching).
A sample for the coronavirus test will be taken from the back of the nose and
throat using a swab of a sample from the back of the throat may cause the
volunteer to gag. When the sample is taken from the back of the nose, they may
experience a stinging sensation and the eyes may become watery.
Arlington Square West 8
Downshire Way Bracknell RG12 1PU
GB
Arlington Square West 8
Downshire Way Bracknell RG12 1PU
GB
Listed location countries
Age
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.
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 | EUCTR2020-002522-91-NL |
| CCMO | NL74576.056.20 |