Safety and Tolerability of the Twice Daily Intra-anal Application of NRL001 Cream for 14 Days

NCT06593730 | Completed Phase 1

• 1 other identifier: NRL001-01/2007(RD)
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is being conducted to evaluate the safety and tolerability after single and repeated twice daily intra-anal applications of 1mL NRL001 cream in stepwise increasing concentrations.

Conditions

Faecal Incontinence

Outcome Measures

Primary Outcomes (4)

• Recumbent and standing blood pressure and pulse rate

  BP and pulse taken lying and standing at screening, on control day and profiling days

  17 days

• Ambulatory 24 hour BP monitoring

  Ambulatory 24 hour BP monitoring on control day and profiling days

  17 days

• 12-lead digital resting ECG

  12-lead digital resting ECG at screening, on control day and profiling days

  17 days

• 3-lead ambulatory 24 hour ECG monitoring

  24 hour HOLTER monitoring at screening, on control day and profiling days

  17 days

Secondary Outcomes (3)

• Plasma concentrations of NRL001

  17 days

• Well being

  17 days

• Adverse events

  17 days

Study Arms (6)

NRL001 cream 0.5%w/w

EXPERIMENTAL

0.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14).

Drug: NRL001 cream 0.5%w/w

NRL001 cream 0.75% w/w

EXPERIMENTAL

0.75%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14).

Drug: NRL001 cream 0.75%w/w

NRL001 cream 1.0% w/w

EXPERIMENTAL

1.0%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14).

Drug: NRL001 cream 1.0%w/w

NRL001 cream 1.5% w/w

EXPERIMENTAL

1.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14).

Drug: NRL001 cream 1.5%w/w

NRL001 cream 2.0% w/w

EXPERIMENTAL

2.0%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14).

Drug: NRL001 cream 2.0%w/w

NRL001 cream 2.5% w/w

EXPERIMENTAL

2.5%w/w NRL001 (1R,2S-methoxamine) 1 mL, twice daily administration (morning and afternoon) for 14 days (study Days D1 to D14).

Drug: NRL001 cream 2.5%w/w

Interventions

NRL001 cream 0.5%w/w DRUG

Also known as: NRL001 (1R,2S-methoxamine) cream 0.5%w/w

NRL001 cream 0.5%w/w

NRL001 cream 0.75%w/w DRUG

Also known as: NRL001 (1R,2S-methoxamine) cream 0.75%w/w

NRL001 cream 0.75% w/w

NRL001 cream 1.0%w/w DRUG

Also known as: NRL001 (1R,2S-methoxamine) cream 1.0%w/w

NRL001 cream 1.0% w/w

NRL001 cream 1.5%w/w DRUG

Also known as: NRL001 (1R,2S-methoxamine) cream 1.5%w/w

NRL001 cream 1.5% w/w

NRL001 cream 2.0%w/w DRUG

Also known as: NRL001 (1R,2S-methoxamine) cream 2.0%w/w

NRL001 cream 2.0% w/w

NRL001 cream 2.5%w/w DRUG

Also known as: NRL001 (1R,2S-methoxamine) cream 2.5%w/w

NRL001 cream 2.5% w/w

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females (only females of non-child-bearing potential or of child-bearing potential while taking medically appropriate contraception)
• Caucasian
• to 60 years of age (included)
• BMI: between 22 and 26 kg.m-2
• BW: between 50 and 100 kg
• Willing and able to provide written informed consent

You may not qualify if:

• General - all subjects
• Previous participation in the trial
• Participation in any other trial during the last 90 days
• Donation of blood or plasma within the last 90 days before recruitment
• History of any clinically relevant allergy
• Presence of acute or chronic infection
• Presence or history of any relevant medical condition or disease (as evaluated on the basis of medical history, physical examination, recumbent and standing blood pressure, treadmill ergometry, clinical laboratory tests \[haematology, clinical chemistry, urinalysis, serology\])
• Presence or history of migraine, frequent headaches, Raynaud phenomenon, urinary urge, signs and symptoms of prostatism
• Presence or history of regular/habitual diarrhoea or constipation; previous anal surgery or trauma, anal fissures, rectal disorders
• Resting systolic blood pressure \> 145 or \< 90 mmHg, diastolic blood pressure \> 95 or \< 50 mmHg
• Positive treadmill ergometry test
• Resting pulse (PR) or electrocardiographic heart rate (HR) \< 55 bpm
• ECG: AV-block (AV-block grade I included), QT \> 480 msec, QTc \> 450 msec, sick-sinus syndrome
• Positive hepatitis (HBs-Ag or HBc-Ab, HCV-Ab) or HIV serology test
• History of alcohol or (social) drug abuse

Sponsors & Collaborators

• Norgine: lead

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: September 19, 2024
• Study Start: August 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: September 1, 2007
• Last Updated: September 19, 2024

Record last verified: 2024-09