A Phase 1 interventional study of AZD2693 in Hepatic Impairment, sponsored by AstraZeneca. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by AstraZeneca · Phase 1, Interventional, and Other
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
This is a Phase I, multicentre, single-dose, non-randomised, open-label, parallel-group study to examine the PK, safety, and tolerability of AZD2693 administered as an subcutaneous injection in male and female participants with mild, moderate, or severe hepatic impairment compared with male and female participants with normal hepatic function (as control). Eight participants with mild impairment (CP Class A); 8 participants with moderate impairment (CP Class B); 8 participants with severe impairment (CP Class C); and 8 to12 participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired participants are planned for study intervention with the goal of having at least 6 evaluable participants within each group. Study participants who self-withdraw after study intervention may be replaced to ensure that at least 6 participants per group are evaluable and complete the study per protocol. An evaluable participant is defined as having adequate plasma PK profile to meet the primary study objective. Child-Pugh scoring, detailed in Table 2, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening: Group 1: Participants with mild hepatic impairment (CP Class A, score of 5 or 6).
Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Group 4: Participants with normal hepatic function.
Study Arms and Duration:
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 35 is below the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Hepatic:
For Healthy:
All participants:
- Body weight ≥ 50 kg; BMI within the range of 18.0 to 40.0 kg/m2 (inclusive) as measured at screening
Exclusion Criteria:
Participants with mild hepatic impairment (CP Class A, score of 5 or 6)
Drug: AZD2693
Participants with moderate hepatic impairment (CP Class B, score of 7 to 9)
Drug: AZD2693
Participants with severe hepatic impairment (CP Class C, score of 10 to 15)
Drug: AZD2693
Participants with normal hepatic function matched on a group level regarding age, body weight, and sex to the impaired groups
Drug: AZD2693
Subcutaneous administration of AZD2693 single dose in participants with hepatic impairment
PK parameters AUCinf
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
Time frame: 85 days
PK parameters AUClast
area under the concentration-time curve from time zero to last time of quantifiable concentration
Time frame: 85 days
PK parameters Cmax
maximum observed plasma concentration
Time frame: 85 days
PK parameters tmax
tmax: time to maximum observed plasma concentration
Time frame: 85 days
PK parameters tlast
tlast: time of the last measurable concentration
Time frame: 85 days
PK parameters t1/2λz
apparent terminal elimination half-life
Time frame: 85 days
PK parameters CL/F
CL/F: apparent clearance
Time frame: 85 days
PK Parameters Vz/F
Vz/F: apparent volume of distribution based on terminal phase
Time frame: 85 days
PK parameters CLR
CLR: Renal clearance of drug from plasma
Time frame: 85 days
PK parameters fe
fe: Percentage of dose excreted unchanged in urine
Time frame: 85 days
PK parameters Ae
Amount of unchanged drug excreted into urine
Time frame: 85 days
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AstraZeneca