Study Evaluating SCA-136 Tolerability With Dose Titration and Food

A Multi-Dose, Double-Blind, Parallel-Group Study of the Effects of Dose Titration and Administration With Food on the Tolerability of SCA-136 in Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420706

Enrollment

120

Registered

2007-01-11

Start date

2006-12-31

Completion date

2006-12-31

Last updated

2007-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.

Interventions

DRUGSCA-136

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men or women, aged 18 to 50 years

Exclusion criteria

* Abnormal vital signs, ECG, or lab results

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026