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ICI176,334-1

Phase 1

Undisclosed | Small Molecules | Other |AstraZeneca PLC|Trials Updated: May 30, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

ICI176,334-1 clinical trials

ICI176,334-1 · 2 trials · 1 indication

Phase 1 2
NCT01415778Bioequivalence of ICI176,334-1 in Japanese Healthy Male SubjectsHealthy
COMPLETED48 Analytics
NCT01415791Oral Mucosal Absorption of ICI176,334-1Healthy
COMPLETED8 Analytics
PHASE1COMPLETED
Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
Healthy
NCT0141577848
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PHASE1COMPLETED
Oral Mucosal Absorption of ICI176,334-1
Healthy
NCT014157918
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Study Endpoints

Primary Endpoints

To investigate the bioequivalence of ICI176,334-1 by assessment of maximum plasma concentration (Cmax)
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of time to Cmax (tmax)
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of area under the plasma concentration curve (AUC)
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the bioequivalence of ICI176,334-1 by assessment of t1/2 of bicalutamide
Blood samples are taken repeatedly for 72 hours and also taken occasionally up to 672 hours after each dose period
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in plasma
Samples are taken at 72 hours after application of the investigational drug
To investigate the presence or absence of oral mucosal absorption of ICI176,334-1 by assessment of concentration of bicalutamide in saliva
Samples are taken at 72 hours after application of the investigational drug

Secondary Endpoints

To assess the safety by assessment of adverse event
Screening day up to 35 to 42 days (follow-up)
To assess the safety by assessment of vital signs
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
To assess the safety by assessment of electrocardiograms (ECGs)
Collect prior to treatment and up to 35 to 42 days (follow-up) after the last dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active 1EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 2EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 3EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet
Active 4EXPERIMENTAL12 subjects will receive ICI176,334-1 and Casodex 80 mg tablet

Interventions

NameTypeDescription
ICI176,334-1DRUGSubject will receive single dose of ICI176,334-1
Casodex 80 mg tabletDRUGSubject will receive single dose of Casodex 80 mg tablet
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Japanese healthy male subjects aged 20 to 45 years * Male subjects should be willing to use barrier contraception ie, condoms, until 3 months after the last dose of investigational...

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Frequently asked questions about ICI176,334-1

What is ICI176,334-1?

ICI176,334-1 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in Phase 1 clinical trials involving healthy male volunteers, with two completed studies and a total enrollment of 56 participants. Its therapeutic indication has not been disclosed.

Who is developing ICI176,334-1?

ICI176,334-1 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored both Phase 1 trials of the compound, including a study of oral mucosal absorption and a bioequivalence study in Japanese healthy male subjects.

What phase is ICI176,334-1 in?

ICI176,334-1 is in Phase 1 development. Both of its clinical trials have been completed, and no trials are currently active. The compound is investigational and has not been approved for any indication.

What clinical trials is ICI176,334-1 in?

ICI176,334-1 has been evaluated in two completed Phase 1 trials: NCT01415791, which studied oral mucosal absorption in 8 healthy male volunteers, and NCT01415778, which assessed bioequivalence in 48 Japanese healthy male subjects. Both trials enrolled participants aged 20 years and older.

Is ICI176,334-1 controlled and randomized in its trials?

Yes. The clinical trials of ICI176,334-1 used a controlled and randomized design. The studies were not double blind and enrolled healthy male volunteers, with a combined total of 56 participants across the two completed Phase 1 trials.

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