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D1000078

Phase 1

Gastric Emptying Time | Small molecule | Gastrointestinal |AstraZeneca PLC|Trials Updated: Nov 4, 2010

D1000078 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

D1000078 clinical trials

D1000078 · 1 trial · 6 indications

Phase 1 1
NCT01224587Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed ConditionsMagnetic Marker Monitoring
COMPLETED5 Analytics
PHASE1COMPLETED
Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions
Magnetic Marker MonitoringUnlock trial analytics

Study Endpoints

Primary Endpoints

The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET)
The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALD1000078 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172),AstraZeneca,Mölndal, Sweden , under fasting condition
2EXPERIMENTALD1000082 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fasting condition
3EXPERIMENTALD1000083 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden ,under fasting condition
4EXPERIMENTALD1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden , under fasting condition
5EXPERIMENTALD100083 marked with approx. 5 mg Fe3O4(E172), AstraZeneca,Mölndal, Sweden, under fed condition
6EXPERIMENTALD1000085 placebo gel matrix tablet marked with approx. 5 mg Fe3O4(E172), AstraZeneca, Mölndal, Sweden , under fed condition

Interventions

NameTypeDescription
D1000078DRUGOral, one single dose
D1000082DRUGOral, one single dose
D1000083DRUGOral, one single dose
D1000085DRUGOral, one single dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Ethnic origin: Caucasian * Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m² * Good health * Written informed consent, after having been informed about benefits and potential risks of the trial Exclusion Criteria: * Diseases which could influence the gastric emptying and gast...

Countries:Germany
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Frequently asked questions about D1000078

What is D1000078?

D1000078 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN) for gastric emptying time, a gastrointestinal measurement. It has been studied in a Phase 1 clinical trial. It is not an approved medicine and remains in clinical development.

What is D1000078 used for?

D1000078 was studied for gastric emptying time, the rate at which the stomach empties its contents, which falls within the gastrointestinal therapeutic area. The research used magnetic marker monitoring to assess gastrointestinal transport. It is investigational and has not been approved for any use.

Who makes D1000078?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of D1000078. The company sponsored the clinical research conducted on this small molecule asset in the gastrointestinal therapeutic area.

What phase is D1000078 in?

D1000078 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials is D1000078 in?

D1000078 has been evaluated in one completed Phase 1 trial, NCT01224587, titled Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions. It enrolled 5 healthy male volunteers aged 18 years and older in Germany and used a controlled, randomized design without double blinding.

What did the D1000078 trial measure?

The completed Phase 1 trial NCT01224587 assessed gastric emptying time along with small intestinal transit time, time for colon arrival, and food effect using magnetic marker monitoring. It enrolled 5 healthy male volunteers in Germany under fasting and fed conditions. The study is complete and no further trials are listed.