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Prototype GDC-0134

Phase 1

Amyotrophic Lateral Sclerosis | Small molecule | Neurology |Roche Holding AG|Last Updated: Mar 1, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Prototype GDC-0134 · 1 trial · 1 indication

Phase 1 1
NCT03237741Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female ParticipantsAmyotrophic Lateral Sclerosis
COMPLETED18 Analytics
PHASE1COMPLETED
Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants
Amyotrophic Lateral Sclerosis
NCT0323774118
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Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of GDC-0134
Periods 1-4: Day 1: pre-dose, post-dose at 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 16 h, Day 2: post-dose 24 h and 36 h, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22

The AUC0-inf is calculated in a plot of concentration of drug in blood plasma against time and extrapolated to infinity.

Area Under the Plasma Concentration-Time Curve up to Time Tau (AUC0-t) of GDC-0134
Periods 1-4: Day 1: pre-dose, post-dose at 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 16 h, Day 2: post-dose 24 h and 36 h, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22

The AUC0-t is calculated in a plot of concentration of drug in blood plasma against time and calculated up to the time of the last measurable GDC-0134 concentration.

Maximum Observed Concentration (Cmax) of GDC-0134
Periods 1-4: Day 1: pre-dose, post-dose at 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 16 h, Day 2: post-dose 24 h and 36 h, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22

Cmax is the maximum observed concentration of drug in blood plasma.

Time to Maximum Concentration (Tmax) of GDC-0134
Periods 1-4: Day 1: pre-dose, post-dose at 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 16 h, Day 2: post-dose 24 h and 36 h, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22

Tmax is the time elapsed from the time of drug administration to maximum plasma concentration.

Apparent Half-Life (t1/2) of GDC-0134
Periods 1-4: Day 1: pre-dose, post-dose at 0.5 hours (h), 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h and 16 h, Day 2: post-dose 24 h and 36 h, Day 3, Day 4, Day 6, Day 8, Day 15 and Day 22

Half-life is defined as the time required for the drug plasma concentration to be reduced to half.

Secondary Endpoints

Percentage of Participants with Adverse Events
From baseline until 21 days after the last dose of study drug up to approximately 16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Sequence 1: ABC1D1EXPERIMENTALSingle dose of reference capsule GDC-0134 (Treatment A) during Period 1. Single dose of prototype capsule GDC-0134 (Treatment B) during Period 2. Single dose of GDC-0134 prototype capsule administered as GDC-0134-in-applesauce preparation under fasting conditions (Treatment C1) during Period 3. Single dose of GDC-0134 prototype capsule administered under fasting conditions in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D1) during Period 4. The washout period between doses will be a minimum of 21 days.
Treatment Sequence 2: ABC2D2EXPERIMENTALSingle dose of reference capsule GDC-0134 (Treatment A) during Period 1. Single dose of prototype capsule GDC-0134 (Treatment B) during Period 2. Single dose of GDC-0134 prototype capsule administered after a high-fat meal (Treatment C2) during Period 3. Single dose of GDC-0134 prototype capsule administered after a high-fat meal in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D2) during Period 4. The washout period between doses will be a minimum of 21 days.
Treatment Sequence 3: BAC1D1EXPERIMENTALSingle dose of prototype capsule GDC-0134 (Treatment B) during Period 1. Single dose of reference capsule GDC-0134 (Treatment A) during Period 2. Single dose of GDC-0134 prototype capsule administered as GDC-0134-in-applesauce preparation under fasting conditions (Treatment C1) during Period 3. Single dose of GDC-0134 prototype capsule administered under fasting conditions in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D1) during Period 4. The washout period between doses will be a minimum of 21 days.
Treatment Sequence 4: BAC2D2EXPERIMENTALSingle dose of prototype capsule GDC-0134 (Treatment B) during Period 1. Single dose of reference capsule GDC-0134 (Treatment A) during Period 2. Single dose of GDC-0134 prototype capsule administered after a high-fat meal (Treatment C2) during Period 3. Single dose of GDC-0134 prototype capsule administered after a high-fat meal in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D2) during Period 4. The washout period between doses will be a minimum of 21 days.

Interventions

NameTypeDescription
Reference capsule GDC-0134DRUGOral administration of a single dose of 200 milligrams (mg) GDC-0134 reference capsule administered as two 100 mg capsules.
Prototype capsule GDC-0134DRUGOral administration of a single dose of 200 mg GDC-0134 prototype capsule administered as one 200 mg capsule.
rabeprazoleDRUGOral administration of 20 mg rabeprazole once daily on Days -3, -2 and -1 as well as on Day 1 two hours prior to each administration of GDC-0134 during Period 4.
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Eligibility Criteria

Age Range30 Years to 65 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female participants between 30 and 65 years of age, inclusive; * Within body mass index range 18.0 to 35.0 kilograms per square meter (kg/m\^2), inclusive; * Female participants will be of non-childbearing potential; * In good health, determined by no clinically signif...

Countries:United Kingdom
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Frequently asked questions about Prototype GDC-0134

What is Prototype GDC-0134 used for?

Prototype GDC-0134 is an investigational small molecule being developed for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in clinical trials.

Who makes Prototype GDC-0134?

Prototype GDC-0134 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Amyotrophic Lateral Sclerosis.

What phase is Prototype GDC-0134 in?

Prototype GDC-0134 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for Amyotrophic Lateral Sclerosis.

What clinical trials is Prototype GDC-0134 in?

Prototype GDC-0134 has one completed clinical trial registered as NCT03237741. This Phase 1 study evaluated the bioavailability of GDC-0134 and the effect of food and a proton pump inhibitor on its pharmacokinetics in healthy female participants. The trial enrolled 18 participants and was conducted in the United Kingdom.

Is Prototype GDC-0134 the same as GDC-0134?

Yes, Prototype GDC-0134 is the same drug as GDC-0134. The name 'Prototype' is used as a placeholder in some databases, but the drug is commonly referred to as GDC-0134 in clinical trial registrations and scientific literature. It is being developed by Roche for Amyotrophic Lateral Sclerosis.