Clinical trials: sponsored by Amgen
Atopic Dermatitis
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
- Trial name
- NCT06268860
- Testing
- Rocatinlimab vial injection, Rocatinlimab prefilled syringe
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Amgen
End-Stage Renal Disease (ESRD)
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring…
- Trial name
- NCT06468826
- Testing
- Avacopan
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Amgen
Cardiovascular Disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study 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)].
- Trial name
- NCT03626662
- Testing
- AMG 890
- Where
- 9 sites in United States, Australia
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Participants
Study of AMG 133 Administered Subcutaneously in Healthy Japanese and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of AMG 133 after single subcutaneous (SC) administration in healthy Japanese and Caucasian participants.
- Trial name
- NCT05056246
- Testing
- AMG 133
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Amgen
Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder.
- Trial name
- NCT00661141
- Testing
- Antizol, Ethanol
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Systemic Lupus Erythematosus
Single Ascending Dose Study of AMG 570 in Healthy Subjects
The purpose of this study is to obtain initial information on the safety and tolerability (effects good or bad), pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of a single…
- Trial name
- NCT02618967
- Testing
- AMG 570
- Where
- 3 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatic Impairment
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic…
- Trial name
- NCT04887064
- Testing
- Sotorasib
- Where
- 5 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Amgen
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when administered orally in healthy volunteers.
- Trial name
- NCT05497557
- Testing
- Omeprazole, Sotorasib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Participants
A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets
The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.
- Trial name
- NCT05327491
- Testing
- Sotorasib
- Where
- 4 sites in United States
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Participants
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).
- Trial name
- NCT05048784
- Testing
- Sotorasib
- Where
- 2 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Amgen
Postmenopausal, Osteopenia
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone…
- Trial name
- NCT01825785
- Testing
- Romosozumab
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Participants
Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.
- Trial name
- NCT05045638
- Testing
- Rosuvastatin, Sotorasib
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Amgen
Atopic Dermatitis, Healthy Volunteers
Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis
This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part A) and adults with moderate to severe atopic dermatitis (Part B).
- Trial name
- NCT00757042
- Testing
- Tezepelumab
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
Safety Study of Tezepelumab (AMG 157) in Healthy Adults
The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.
- Trial name
- NCT00972179
- Testing
- Tezepelumab
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Amgen
Heart Failure, Healthy Volunteer
Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients
To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986 in heart failure patients (Part C).
- Trial name
- NCT03276728
- Testing
- AMG 986 IV, AMG 986 PO
- Where
- 25 sites in United States, Australia and 7 more
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- Amgen
Osteoporosis
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients with stage 4 renal impairment (RI) or stage…
- Trial name
- NCT01833754
- Testing
- Romosozumab
- Where
- 5 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Heart Failure
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function
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.
- Trial name
- NCT03318809
- Testing
- AMG 986
- Where
- 4 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation.
- Trial name
- NCT02641353
- Testing
- Apremilast Tablet, Apremilast Oral Suspension
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Volunteers
A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults
The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose…
- Trial name
- NCT02777554
- Testing
- Apremilast IR, Apremilast XL
- Where
- 2 sites in United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Amgen