Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05481411
Other study ID # 20220009
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 13, 2022
Est. completion date May 31, 2023

Study information

Verified date September 2023
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 31, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male or female participants of nonchildbearing potential, between 18 and 75 years of age (inclusive) at the time of Screening. - Body mass index between 18.0 and 40.0 kg/m^2 (inclusive) at the time of Screening. Participants with Normal Hepatic Function Only: • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee). Participants with Hepatic Impairment Only: • Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings. Exclusion Criteria: - History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). - Estimated glomerular filtration rate < 60 mL/min/1.73m^2 (Groups 1-3) or < 50 mL/min/1.73m^2 (Group 4 only) by Modification of Diet in Renal Disease formula at Screening or Check-in. - Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer) before receiving olpasiran. - Participants who were previously exposed to olpasiran. - Female participants with a positive pregnancy test at Screening or Check-in. Participants with Normal Hepatic Function Only: - Positive hepatitis panel. Participants whose results are compatible with prior immunization may be included. - Alanine aminotransferase and aspartate aminotransferase elevations > 3x upper limit of normal at Screening or Check-in. Participants with Hepatic Impairment Only: - Positive for hepatitis B surface antigen. Participants with positive hepatitis B core antibody may be included if hepatitis B surface antigen is negative. Participants with positive hepatitis B surface antibody may be included (consistent with prior vaccination). - Active malignancy of any type. Participants with a history of malignancy that has been eradicated with supporting medical documentation indicating that there is no residual malignancy detected in the past 2 years will be allowed. - Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olpasiran
Subcutaneous injection

Locations

Country Name City State
United States Orlando Clinical Research Center Orlando Florida
United States Inland Empire Clinical Trials, LLC Rialto California
United States The Texas Liver Institute, Inc. San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Observed Serum Concentration (Cmax) of Olpasiran Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Primary Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Primary Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Secondary Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a]) Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Secondary Maximum Inhibitory Effect (Imax) of Plasma Lp(a) Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Secondary Time to Reach Imax of Lp(a) Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85
Secondary Number of Participants Who Experience an Adverse Event (AE) Up to Day 85
Secondary Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations Up to Day 85
Secondary Number of Participants With Clinically Significant Changes 12-lead Electrocardiogram (ECG) Measurements Up to Day 85
Secondary Number of Participants with Clinically Significant Changes in Vital Signs Up to Day 85
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05009680 - A Single and Repeat Dose Trial in Participants With Hepatic Impairment Phase 1/Phase 2
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Terminated NCT05517226 - Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment Phase 1
Completed NCT03983161 - A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment Phase 1
Completed NCT04546789 - Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK Phase 1
Completed NCT03282513 - A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function Phase 1
Recruiting NCT05976321 - A Study of TAK-279 in Adults With or Without Liver Damage Phase 1
Completed NCT04473664 - A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment Phase 1
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Completed NCT03290443 - A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment. Phase 1
Completed NCT02245243 - Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment Phase 1
Completed NCT02244827 - Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment Phase 1
Completed NCT02004587 - Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers Phase 1
Completed NCT01621633 - A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers Phase 2
Completed NCT01493869 - Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects Phase 1
Completed NCT04482270 - A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function Phase 1
Completed NCT02115347 - Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014) Phase 1
Recruiting NCT04950764 - An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Phase 1
Completed NCT06161259 - Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment Phase 1
Completed NCT05409911 - A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants Phase 1