Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)



Status:Recruiting
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 65
Updated:3/13/2019
Start Date:July 30, 2018
End Date:August 31, 2020
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose
study in subjects with elevated plasma Lipoprotein(a) [Lp(a)]. AMG 890 will be evaluated in
approximately 64 subjects to assess safety, tolerability, pharmacokinetics and
pharmacodynamic effects.


Inclusion Criteria:

- Men and women with ages between 18 and 65 years old, inclusive.

- Protocol-defined elevated plasma Lp(a) level.

- Body mass index (BMI) greater than or equal to 18 and less than or equal to 32 kg/m2,
at screening.

- Women must be of non-reproductive potential.

- Other Inclusion criteria may apply

Exclusion Criteria:

- Currently receiving treatment in another investigational device or drug study.

- Women who are lactating/breastfeeding or who plan to breastfeed while on study or
through 90 days after receiving the last dose of investigational product (for subjects
who withdraw prior to end of study).

- History or evidence of a clinically significant disorder, condition or disease that
would pose a risk to subject safety or interfere with the study evaluation, procedures
or completion.

- History or clinical evidence of bleeding diathesis or any coagulation disorder.

- History or clinical evidence of peripheral neuropathy.

- Other Exclusion criteria may apply
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