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Human ADME Study of [14C]-AZD1390

ConditionAdvanced Solid Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAstraZeneca

About this trial

This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \[14C\]-AZD1390.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,

ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,

Predicted life expectancy ≥ 12 weeks,

Adequate organ and marrow function,

Disqualifiers

History or presence of myopathy or raised CK > 5 × ULN at screening,

History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,

History or presence of clinically significant hepatic disease,

History of epileptic disorder or any seizure history unrelated to tumour,

Trial design

Design model

Single group

Treatments tested in this trial

  • AZD1390

    Drug

    single dose

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: AZD1390Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Amount excreted (Ae) (urine)

Time frame
6 Weeks
2

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Cumulative Amount excreted (CumAe) (urine)

Time frame
6 Weeks
3

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Amount excreted (Ae) (feaces)

Time frame
6 Weeks
4

The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

Cumulative Amount excreted (CumAe) (feaces)

Time frame
6 Weeks

Secondary outcomes

1

The phamrmacokinetic(s) of AZD1390 metabolite

Analysis of plasma: Maximum observed concentration (Cmax)

Time frame
6 weeks
2

The phamrmacokinetic(s) of AZD1390 metabolite

Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)

Time frame
6 weeks
3

The phamrmacokinetic(s) of AZD1390 metabolite

Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)

Time frame
6 weeks
4

The phamrmacokinetic(s) of AZD1390 metabolite

Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: