SMP-028/ketoconazole drug: drug interaction study

An exploratory, randomised, open-label, two-period, crossover study in healthy subjects to evaluate the effect of ketoconazole on the pharmacokinetics of SMP-028

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41050179

Enrollment

Registered

2010-04-15

Start date

2010-03-18

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Asthma Respiratory Asthma

Interventions

Subjects will be randomised (in a 1:1 ratio) into one of two treatment sequences (Treatment A followed by Treatment B or Treatment B followed by Treatment A): Treatment A consists of Ketoconazole 400

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy subjects aged 18 to 55 years who are in good health as determined by past medical history, physical examination, electrocardiogram, clinical safety laboratory tests and urinalysis

Exclusion criteria

Exclusion criteria: Standard exclusion criteria for a healthy volunteer study

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: 1. Primary endpoints: Comparative SMP-028 exposure between treatment periods (AUC[0-8] and C[max]) over 72 hours 2. Secondary endpoints: Comparative SMP-028 exposure between treatment periods (other pharmacokinetic parameters), and exposure levels of the metabolites of SMP-028 over 72 hours	—

Secondary

Measure	Time frame
Safety endpoints: 1. The proportion of subjects with adverse events (AEs) 2. Changes in standard laboratory safety tests 2.1. haematology 2.2. clinical chemistry 2.3. urinalysis 3. Concomitant medication review 4. Vital signs 5. Complete physical examinations 6. 12-lead ECG	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026