Phase 1
N=12
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03318809 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: AMG 986 Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast) — 80,000; 64,500 hr*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- AMG 986 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AMG 986 Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast) |
80,000; 64,500 | — |
| PRIMARY AMG 986 PK Parameter: Maximum Observed Plasma Concentration After Dosing (Cmax) |
10,600; 7520 | — |
| PRIMARY AMG 986 PK Parameter: Terminal Phase Half-Life (t1/2,z) |
18.4; 21.1 | — |
| PRIMARY AMG 986 PK Parameter: Time of Maximum Plasma Concentration (Tmax) |
1.1; 1.5 | — |
| PRIMARY AMG 986 PK Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUCinf) |
80,800; 65,800 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
2; 1; 0; 0 | — |
Summary
A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy participants and participants with severely impaired kidney function.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects, who are > or = 18 and or = 18 and or = 4 weeks prior to screening, and expected to remain on this dose and medication for the entire duration of the study
- Willing to maintain current general diet and physical activity regimen
- Renal function in 1 of the following 2 categories at the time of screening: Group 1 - Severe Renal Impairment (eGFR 15 to 29 mg/min/1.73 m^2) and not anticipated to require hemodialysis or renal transplantation, and anticipated to have renal function appropriate to severe renal impairment for the duration of the study OR Group 2 - Normal renal function (eGFR > or = 90 mg/min/1.73 m^2)
Exclusion Criteria
- Subjects whose second modification of diet in renal disease (MDRD) eGFR result on day -1 is not within 15% of the first eGFR result performed during the screening period. Healthy volunteers who have normal renal function, but show a difference greater than 15% in eGFR based on MDRD during the screening period, will be included in the trial at the discretion of the investigator and the sponsor after a 24-hour creatinine clearance has been performed that meets eligibility criteria.
- Subjects who are the recipient of a renal transplant and/or are on immunosupressants.
- Subjects with a history of hospitalization for heart disease or angina within 4 months of screening.
- Current or prior malignancy within 5 years of enrollment with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, and adenocarcinoma of the prostate Stage I or IIa (defined as T1, T2a or T2b, N0-, M0 with documented serum prostate-specific antigen (PSA) < 20 ng/mL and Gleason score ≤ 7) per the American Joint Committee on Cancer (AJCC) primary tumor, regional lymph nodes, and distant metastasis system.
- Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HepCAb) at screening
- History or evidence of any other clinically significant disorder, condition or disease with the exception of those outlined above that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject previously has entered this study or has been previously exposed to AMG 986.
- Heart rate ≥ 100 beats per minute after 5 minutes of rest or an untreated symptomatic bradyarrhythmia within 1 month prior to enrollment.
- Known history of drug or alcohol abuse within last 12 months.
- Currently receiving treatment in another investigational device or drug study or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug study(s) prior to receiving the dose of investigational product (AMG 986).
Data sourced from ClinicalTrials.gov (NCT03318809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.