Phase 1
Completed N=72
A Single Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of AZD9567.
Safety · Tolerability · Pharmacokinetics · Pharmacodynamics
Source: ClinicalTrials.gov NCT02512575 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events — 0; 0; 1; 0 Participants
Summary
This is a Phase I, first-in-human (FIH), randomized, single-blind, placebo-controlled, single ascending dose sequential group study in healthy male subjects. The objectives are to study the safety, tolerability, pharmacokinetics and effects on glucose homeostasis (pharmacodynamics) of AZD9567, an oral differentiated non-steroidal selective glucocorticoid receptor modulator (SGRM). The study will also assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of prednisolone 60 mg in comparison with high doses of AZD9567 and placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of AZD9567 by Assessing the Number of Participants With Adverse Events |
0; 0; 1; 0; 0; 2 | — |
| PRIMARY Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Observed Maximum Plasma Concentration (Cmax) |
184.9; 751.6; 1327; 2536; 4261; 5835 | — |
| PRIMARY Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Time to Reach Maximum Plasma Concentration(Tmax) |
0.50; 0.75; 0.51; 0.75; 1.00; 1.00 | — |
| PRIMARY Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Terminal Half-life (t½λz) |
4.716; 5.444; 3.929; 4.199; 5.286; 5.297 | — |
| PRIMARY Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC(0-last)) |
940.6; 5069; 7598; 13860; 31600; 41850 | — |
| PRIMARY Rate and Extent of Absorption of Single Ascending Doses of AZD9567 by Assessment of Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) |
1007; 5266; 7670; 14000; 31840; 42080 | — |
| SECONDARY Secondary Outcome: Relative Change From Baseline of AUC0-4h for Plasma Glucose to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT]) |
1.04; 1.01; 1.07; 1.06; 1.08; 1.17 | — |
| SECONDARY Relative Change From Baseline of AUC0-4h for Serum Insulin to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT]) |
1.19; 1.20; 1.03; 1.04; 0.999; 0.980 | — |
| SECONDARY Relative Change From Baseline of AUC0-4h for Serum C-peptide to Assess the Effects on Glucose Homeostasis (Oral Glucose Tolerance Test [OGTT]) |
1.06; 1.04; 1.02; 0.933; 0.919; 1.00 | — |
Eligibility Criteria
Inclusion Criteria
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Normal OGTT at screening ( 85 beats per minute (bpm).
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy.
- Prolonged QTcF > 450 ms or family history of long QT syndrome.
- PR(PQ) interval shortening 110 ms but 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation
Data sourced from ClinicalTrials.gov (NCT02512575). 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. Informational only — not medical advice.